Manufacturing review: a manufacturing review was performed.The lot met all release criteria.Visual/microscopic inspection: the sample was returned.The balloon appeared to have been previously inflated.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 5mm x 100mm balloon.The catheter was kinked approximately 130cm 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 kink.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¿ 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 present at the location of the catheter shaft break.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is confirmed for a partial circumferential catheter shaft break just distal to the y-hub, which resulted in the inability to inflate the balloon.Excessive sanding of the catheter under the strain relief is the root cause for the catheter detachment.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.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.(b)(4).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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