It was reported that during a filter placement procedure, the device was allegedly failed to advance.It was further reported that the automatic center bar was broken, and the filter stayed in the guiding sheath.The procedure was completed using another device.There was no reported patient injury.
|
The catalog number identified has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 11/2024).
|
It was reported that during a filter placement procedure, the device was allegedly failed to advance.It was further reported that the automatic center bar was broken, and the filter stayed in the guiding sheath.The procedure was completed using another device.There was no reported patient injury.
|
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one femoral delivery system was returned for evaluation.The pusher catheter was inserted into touhy adaptor and filter storage tube.The filter was noted to partially exposed form the distal tip of the introducer sheath.The pusher wire was noted to be detached from the pusher catheter.Skiving was noted to the storage tube due to advancement of the filter.Two fluoroscopic images were reviewed.The first image shows a sheath traveling up from the right groin to the level at the top of the l2 vertebral body.Within this sheath, closer to the groin, appears to be a constrained vena cava filter.In the second image, a venogram is performed with a wire visible in the left renal vein.The same sheath mentioned from the previous image is no longer visualized, nor is the constrained vena cava filter.Therefore based on the provided images, the reported failure to advance and detachment issues can not be confirmed.Two electronic photos were provided and reviewed.The first photo shows the pusher catheter was held in his hand by the physician, the pusher wire was noted to be detached.The second photo shows the partially exposed filter from the introducer sheath distal tip.Therefore, based on the provided photo the reported failure to advance and detachment issues can be confirmed.Based on these findings, the investigation is confirmed for the reported advancement issue as the filter was noted to be partially exposed from the introducer sheath and skiving was noted to the storage tube.The investigation is also confirmed for the reported detachment issue as the pusher wire was noted to be detached from the pusher catheter.A definitive root cause for the reported failure to advance and detachment of device or device component issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|