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As originally reported, prior to use during an endovascular revascularization procedure of the left leg, via access in the right groin, the tip of a flexor ansel guiding sheath was found to be "faulty" upon opening the device package.A wire would not pass through the damaged tip.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and evaluation of the device on (b)(6) 2023, one of the dilators was split at the tip.
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E1: name and address - address line 2: (b)(6).E3: occupation = regulatory affairs manager.Summary of event: as originally reported, prior to use during an endovascular revascularization procedure of the left leg, via access in the right groin, the tip of a flexor ansel guiding sheath was found to be "faulty" upon opening the device package.A wire would not pass through the damaged tip.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and evaluation of the device on (b)(6) 2023, one of the dilators was split at the tip.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.One of the 0.038-inch dilators was split and out-of-round at the tip.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number.One relevant non-conformance was noted on the lot for bends/kinks; however, all affected product was scrapped, and there are 100% inspections in place to capture the non-conformance.There were no non-conformances or additional relevant complaints found on the dilator subassembly lots.The product ifu states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.Although one relevant non-conformance was noted on the lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that non-conforming product exists in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that shipping/handling of the device contributed to this event, as the tip damage was noted upon opening the device packaging.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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