Events

Rappel de Device Recall Flextome Cutting Balloon Device OvertheWire Delivery System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Boston Scientific Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    50487
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0621-2009
  • Date de mise en oeuvre de l'événement
    2008-11-21
  • Date de publication de l'événement
    2008-12-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75489
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Transluminal Coronary Angioplasty Percutaneous Catheters - Product Code LOX
  • Cause
    For one batch/lot of flextome cutting balloon (otw), an incorrect compliance chart was packaged inside the sterile pouch. for the affected batch/lot, the compliance chart packed inside the pouch of the 4.0mm diameter flextome cutting balloon device is for a 3.5mm diameter flextome cutting balloon device. this labeling discrepancy could create a procedural delay as users seek to explain the discr.
  • Action
    An Urgent medical Device Field Correction, dated November 21, 2008, was sent to affected customers/hospitals for delivery on November 24, 2008. The letter described the issue; identified product affected; use or further distribution of the affected product should be ceased immediately; and a correct compliance chart included with the notification is to be secured to the outer sterile pouch. Affected product is not asked to be returned as the correct compliance chart is enclosed and is to be secured to the outer sterile pouch. A Reply Verification Tracking Form is to be completed and faxed to Customer Service Call Center.

Device

Device Recall Flextome Cutting Balloon Device OvertheWire Delivery System
  • Modèle / numéro de série
    Batch/Lot # EG5577
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution --- including states of AL, AR, AZ, CA, CO, GA, HI, ID, IL KS, MA, MD, MI, MN, MO, MS, NV, NY, OH, PA, TN, TX, UY, VA, and WI.
  • Description du dispositif
    Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland: Interventional Technologies Europe Ltd., A subsidiary of Boston Scientific Letterkenny, County Donegal, Republic of Ireland. US Customer Service 888-272-1001. || The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as Atherotomy, allows dilation of the target lesion with less pressure. || Indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA