Events

Rappel de SPYSCOPE DS ACCESS AND DELIVERY CATHETER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BOSTON SCIENTIFIC LTD..

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
    100652
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-12-15
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Potential for these devices to not perform as intended. an internal investigation found that the working channel sleeve may not be adequately bonded inside of these devices. this may result in the working channel sleeve protruding from the camera cap located at the distal tip of the catheter. the most common injury reported has been minor tissue damage caused by the protruding working channel sleeve scraping along the duct walls during the procedure .

Device

SPYSCOPE DS ACCESS AND DELIVERY CATHETER
  • Modèle / numéro de série
    Model Catalog: M00546600 (Lot serial: 21169977); Model Catalog: M00546600 (Lot serial: 21159396); Model Catalog: M00546600 (Lot serial: 21332229); Model Catalog: M00546600 (Lot serial: 21212151); Model Catalog: M00546600 (Lot serial: 21264826); Model Catalog: M00546600 (Lot serial: 21237929)
  • Description du dispositif
    SPYSCOPE DS ACCESS AND DELIVERY CATHETER
  • Manufacturer
    BOSTON SCIENTIFIC LTD.

Manufacturer

BOSTON SCIENTIFIC LTD.
  • Adresse du fabricant
    MISSISSAUGA
  • 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
    HC