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 guidewire and an introducer needle were returned for evaluation.Gross visual, microscopic visual, dimensional evaluations were performed on the returned device.The investigation is confirmed for the reported stretched and identified material protrusion and fracture issues.During sample evaluation, the guidewire was noted to be uncoiled on the distal end.Further, the guidewire was observed to be unraveled distal to the distal tip.The flat inner core wire was noted to be protruding the coils of the guidewire, proximal to the distal end of the guidewire.The flat inner core wire was noted to have a complete circumferential break at the distal end.However, the investigation is inconclusive for the reported failure to advance issue as the exact circumstances at the time of the reported event cannot be verified.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.A definitive root cause could not be determined based upon the available 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: 07/2024).
|