No hospital/medical records or medical images have been made available to the mfr.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the mfr for eval.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
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The lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Visual inspection: the sample was returned.No anomalies were noted to the strain relief or the y-hub.Functional/performance evaluation: the patency was tested using an in-house.035¿ guidewire and passed without issue.The inflation hub was connected to an inflation device and an attempt was made to inflate the balloon with water.Upon inflation, water was observed to be leaking out the distal end of the strain relief.The strain relief was removed and a partial circumferential break was noted to the catheter, located at the distal end of the y-hub.The catheter break was examined under magnification and the edges of the break were jagged.Sanding marks were noted on the catheter at the point of the break.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is confirmed for a partial circumferential catheter break just distal to the y-hub, resulting in the reported leak.It is unknown whether handling techniques by the user as they removed the catheter from the packaging or prepped the device may have contributed to the reported issue.Based upon the available information a definitive root cause has not been determined.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Additional warnings, precautions and directions for use of the ultraverse 035 pta dilatation catheter are included in the current instructions for use (ifu).
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