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E1: customer phone = (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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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As reported, during transluminal angioplasty of the lower limbs, the tip of a triforce peripheral crossing set's sheath separated and remains in the patient.Access was obtained in the superficial femoral artery to target a very calcified lesion in the distal superficial femoral artery.The access site was not scarred.Because the lesion was very calcified, progression of an unspecified guide was difficult, and it was directed toward the subintimal space.The user attempted to "return to the light" with a cxi catheter; however, this was unsuccessful.The cxi catheter reportedly did not malfunction, but would not cross the very calcified lesion.A cook wire guide, used during the procedure, did not malfunction.The user then changed the puncture site and obtained access medial to the limb in an attempt to cross the lesion, without major progression.The complaint device was then used, which progressed a "little more" than with other attempts; however, the guide always led to the subintimal space.A power injector was used during the procedure.During the attempts to advance the complaint device, the radiopaque tip of the sheath separated.The separated tip remains in the patient.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.
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Summary of event: as reported, during transluminal angioplasty of the lower limbs, the tip of a triforce peripheral crossing set's sheath separated and remains in the patient.Access was obtained in the superficial femoral artery to target a very calcified lesion in the distal superficial femoral artery.The access site was not scarred.Because the lesion was very calcified, progression of an unspecified guide was difficult, and it was directed toward the subintimal space.The user attempted to "return to the light" with a cxi catheter; however, this was unsuccessful.The cxi catheter reportedly did not malfunction but would not cross the very calcified lesion.A cook wire guide, used during the procedure, did not malfunction.The user then changed the puncture site and obtained access medial to the limb in an attempt to cross the lesion, without major progression.The complaint device was then used, which progressed a "little more" than with other attempts; however, the guide always led to the subintimal space.A power injector was used during the procedure.During the attempts to advance the complaint device, the radiopaque tip of the sheath separated.The separated tip remains in the patient.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.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record found one relevant non-conformance on four devices from a sub-assembly lot; however, all affected product was scrapped.A review of complaint history found two additional complaints for this lot number and failure mode.The product ifu cautions, "be sure the wire guide tip is extended beyond the cxi support catheter tip at all times, and that the cxi support catheter tip is extended beyond the flexor sheath tip at all times".A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and ifu suggests that there is evidence the device was manufactured to specification.Although one relevant non-conformance was noted on a sub-assembly lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this event, as it is likely that the tip became damaged and subsequently separated during attempts to advance the sheath into the very calcified lesion.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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