Events

Rappel de Device Recall iCross Coronary Imaging Catheter

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
    58405
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2419-2011
  • Date de mise en oeuvre de l'événement
    2011-03-28
  • Date de publication de l'événement
    2011-06-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99277
  • 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
    Catheter, intravascular, diagnostic - Product Code DQO
  • Cause
    Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. expanded: boston scientific is initiating a recall of all icross coronary imaging catheters because they have received and confirmed 8 occurrences of catheter tip detachments due to embrittlement.
  • Action
    Boston Scientific " Important Customer Notification" letters dated March 14, 2011 were hand delivered to customers by Boston Scientific sales representatives starting on March 28th, 2011. The sales representatives verbally reviewed information. A tracking log will be maintained document completion of the customer notifications. The letter described the product, problem and possible root cause as well as one corrective action, a change in sterilization method from Gamma to E-beam implementation. Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter dated May 26, 2011, to all affected customers. Customers were instructed to Identify and discontinue use of any affected product within their inventory and to segregate it immediately and return it to Boston Scientific

Device

Device Recall iCross Coronary Imaging Catheter
  • Modèle / numéro de série
    All lots are impacted
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Japan, Trinidad, Tobago, and American Virgin Islands.
  • Description du dispositif
    Boston Scientific, Atlantis ¿ SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, USE BY 2011-05, REF 39014, UPN H749390140, Sterile R Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 || The intended use as stated in Japan Shonin 21200BZY00484000: This product is an imaging catheter with built-in ultrasonic transducer that sends ultrasound waves inside the blood vessel to perform B-mode ultrasonagraphy. The indications for use as stated in the 510(k) and DFU 90606867: The Atlantis coronary catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
  • 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