Events

Rappel de Device Recall PowerCross .018 OTW PTA Dilation 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 Medtronic Inc.

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
    75780
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0892-2017
  • Date de mise en oeuvre de l'événement
    2016-11-10
  • Date de publication de l'événement
    2016-12-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151248
  • 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, angioplasty, peripheral, transluminal - Product Code LIT
  • Cause
    Medtronic identified an issue with specific models and lots of the powercross .018 over the wire (otw) percutaneous transluminal angioplasty (pta) dilatation catheter. during an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. the catheter outer shafts were pinched and deformed at the proximal balloon bond. bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.
  • Action
    Medtronic verbally communicated about the issue on November 20. 2016, to affected customers. Additionally, consignees were hand delivered by Field Sales Representatives a Medtronic "Urgent Medical Device Recall" letter dated November 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall. Advised consignees to immediately identify, quarantine the affected product, and return it to Medtronic. Requested consignees to complete and email the Customer Confirmation Certificate to RS.CFQFCA@medtronic.com or fax it to Medtronic at 651-367-0612, attention: Customer Focused Quality. For questions, contact your Medtronic representative. If you require assistance in contacting your representative, please contact Medtronics National Answering Service at 800-633-8766.

Device

Device Recall PowerCross .018 OTW PTA Dilation Catheter
  • Modèle / numéro de série
    UDI/Product Lot/Serial Product Number UPN/GTIN Number 00821684046647 A358626 AB18W030100150 00821684046883 A357386 AB18W060100150 00821684046722 A357070 AB18W040100150 00821684046777 A358043 AB18W050040150 00821684046722 A356360 AB18W040100150 00821684046777 A357348 AB18W050040150 00821684046562 A359219 AB18W025040150
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    NY, NC, WA
  • Description du dispositif
    ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. || The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Adresse du fabricant
    Medtronic Inc, 710 Medtronic Pkwy, NE Mailstop LS245, Minneapolis MN 55432-5603
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA