Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Visual inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 5mm x 120mm balloon.The balloon was returned in its original folded configuration.The catheter was kinked 8.3cm, 11.4cm, and 13.4cm from the distal tip.However after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kinks.No kinks were reported by the user.No anomalies were noted to the strain relief or the y-hub.Functional/performance evaluation: the patency was tested using an in-house.035¿ guide wire and the guide wire was unable to be advanced past the kinks in the catheter.The strain relief was removed and a partial circumferential catheter shaft break was observed at the distal end of the y-hub.Sanding marks were noted on the catheter underneath the strain relief and at the location 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 device was returned.The investigation is confirmed for a partial circumferential catheter shaft break just distal to the y-hub.The investigation is inconclusive for failure to advance, as functional testing could not be performed due to the poor sample condition (i.E.Kinked catheter).Excessive sanding of the catheter under the strain relief is the root cause for the partial break in the catheter.Per the reported event details, the tracking path was mildly calcified.Therefore, it is possible that patient factors contributed to the failure to advance through the lesion.Labeling review: the current ultraverse 035 pta balloon catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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.
|