Events

Rappel de Device Recall Spectranetics TurboElite Laser Atherectomy Catheters

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 Spectranetics 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
    77474
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2863-2017
  • Date de mise en oeuvre de l'événement
    2017-06-06
  • Date de publication de l'événement
    2017-07-14
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156104
  • 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, peripheral, atherectomy - Product Code MCW
  • Cause
    Potential for flouroscopially visible marker band at the tip of the rapid exchange turbo elite atherectomy catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.
  • Action
    Spectranetics sent a Field Safety Notice letter via certified mail on June 7, 2017, to all customers who have ordered the affected model numbers since 23May2016 reiterating the risks associated with off-label use of the device (i.e., not activating the laser within a stent and not until all contrast media is flushed from the treatment area). The product continues to meet specifications and does not need to be returned. Customers with questions were encouraged to call their local Spectranetics Sales Representative or Spectranetics Customer Service Department. Customer Service can be reached by phone at 800-231-0978 (Option 2), by fax at 877-447-2022, or by email at customer.service@spnc.com. Customer Service is available Monday thru Friday, From 7AM-5PM MST.

Device

Device Recall Spectranetics TurboElite Laser Atherectomy Catheters
  • Modèle / numéro de série
    Model Number 414-159 Catheter Diameter 1.4mm,  Model Number 417-156 Catheter Diameter 1.7mm, and Model Number 420-159 Catheter Diameter 2.0mm.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands
  • Description du dispositif
    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters || Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
  • Manufacturer
    Spectranetics Corporation

Manufacturer

Spectranetics Corporation
  • Adresse du fabricant
    Spectranetics Corporation, 9965 Federal Drive, Colorado Springs CO 80921-3617
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA