Events

Rappel de ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a left ventricular pacing lead)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Boston Scientific Pty 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
    RC-2015-RN-01192-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-07
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01192-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Boston scientific is recalling certain lots of 9fr acuity pro coronary sinus outer guide catheters due to potential for separation of the proximal handle from the shaft. boston scientific's investigation concluded that if the hub and shaft are aligned off-centre in the bonding equipment during manufacturing, the result may be a reduced bond, which may separate during cutting. the affected products were manufactured during the time period when the equipment was likely to be misaligned.The most serious injury foreseeable with unexpected hub detachment is a moderate delay in the procedure to reposition a dislodged lead. boston scientific has received reports of handle separations during the cut and removal process; there have been no reports of patient harm.
  • Action
    Customers are advised to immediately segregate all affected products to ensure that it will not be used and to ship the stock back to Boston Scientific for replacement with unaffected stock. This action has been closed-out on 24/08/2016.

Device

ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a...
  • Modèle / numéro de série
    ACUITY Pro 9 Fr Guide Catheter ( used to access the coronary venous system for implantation of a left ventricular pacing lead)Model Numbers: 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, 8119Multiple Lot Numbers affectedARTG Number: 222220
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 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
    DHTGA