Events

Rappel de Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract)

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-2013-RN-01141-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-08
  • 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-2013-RN-01141-1
  • 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 has received reports from the field that the tip of the dilator has separated from the body of the dilator during procedure. if the tip broke off as the shaft was being advanced near the ureteopelvic junction (upj), then inadvertent blunt trauma to the renal parenchyma or renal hilar vessels could occur. this could produce anything from a small haematoma up to haemorrhage requiring medical therapy (transfusion), radiologic intervention (embolisation) or surgery (nephrectomy). however, in most cases the attempted removal of the tip would result in a second intervention. unless the tip fell off in the packaging or at placement over the guidewire the defect is unlikely to be detected prior to the procedure.
  • Action
    Boston Scientific are requesting users to inspect current stock and quarantine affected batches. Affected product can be returned to Boston Scientific for replacement or a credit note.

Device

Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage...
  • Modèle / numéro de série
    Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set (used to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract)Catalogue Numbers: 250-227, 250-228 and 250-229 Material Numbers: M0062502270, M0062502280 and M0062502290Multiple Lot Numbers affectedARTG Number: 126446
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • 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