As reported, during a percutaneous transluminal angioplasty, the radiopaque band of a flexor introducer sheath was unable to be visualized under radiography.A section of the device did not remain inside the patient¿s body.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.Additional event information has been requested.
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Description of event: reportedly, during a percutaneous transluminal angioplasty, the radiopaque band was not visible on a flexor introducer sheath.Investigation ¿ evaluation: a visual inspection and functional testing of the returned unused devices was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.Although the used complaint device was not received, the user facility returned 13 unused devices from the complaint lot, reported in (b)(4), to cook for investigation.Physical examination of the returned unused devices confirmed no presence of the rb at distal end all complaint devices.During tabletop testing, the caps were disassembled from check-flo valves, which showed that the rb was present just below the flares.Per dwg_60049 ((b)(4)) rev035, the radiopaque marker should be 2-3mm from the distal tip of the sheath.Results from the dfa are evidence that the devices were manufactured out of specification.A review of the device history record found no non-conformances related to the reported failure mode.A database search for complaints on the reported lot found 11 additional complaints from the field that were reported for the same failure mode ((b)(4)).At this time, cook concluded that that complaint device is non-conforming and that additional non-conforming product from this lot exists in the field.Cook also reviewed product labeling.The product ifu does not provide information related to the reported failure mode.A relevant capa, pr218465, was opened 21feb20218 in response to the 3 ksaw-6.0-38-80-rb-shtl-hc devices received for rb in the wrong location (rb located 24-25mm from distal tip instead of 2-3mm).As a part of this capa, quality control implemented a new step to inspect the rbs with a light fixture.The complaint lot was manufactured prior to implementation of the new qc inspection step.With implementation of the new qc inspection step, cook has concluded that sufficient inspection activities are now in place to identify this failure mode prior to distribution.Cook has concluded that a manufacturing deficiency contributed to this incident.The investigation determined that two lots were manufactured incorrectly.A recall-removal was initiated for the two affected lots.Investigation into complaint and nonconformance history found no evidence of additional affected lots.The failure mode is highly detectable by end users and a new inspection step was implemented 01jun2021.The complaint lots were manufactured prior to implementation of the inspection step.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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