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 ultraverse rx pta dilatation catheter was received in three segments for evaluation.During visual evaluation, segment (1) consisted of the proximal end of the catheter.The catheter was noted to be torn at the guidewire exit port with metal material being exposed.No damage was noted to the inflation hub.Segment (2) consisted of the remaining detached portion of the proximal end of the balloon with partial guidewire exposed.Segment (3) consisted of clear catheter tubing with a tear at the guidewire exit port and partial guidewire present with bunching.Functional testing could not be performed due to the condition of the returned sample.Therefore, the investigation is inconclusive for the reported uncomplicated balloon rupture as no evidence of rupture could be seen.The investigation is confirmed for the identified detachment as the catheter was received detached in three segments.A definitive root cause for the reported uncomplicated balloon rupture and identified detachment 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.(expiry date: 01/2024).
|