Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as originally reported, prior to patient contact, a bentson straight fixed core wire guide uncoiled near the distal end.Another wire was used to complete the procedure.There have been no reported adverse effects to the patient.Upon return and initial evaluation of the device at cook on 11apr2023, the wire was not unraveled; however, the inner wire was protruding from the wire guide.A handwritten note on the device label noted that the wire was found damaged upon removal from the package.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and manufacturing instructions were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.Mandril protrusion was noted at approximately 7.5-centimeters from the distal tip.Unraveling was not noted.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.Additionally, no non-conformances or additional complaints were found on any lot packaged by the same personnel as the complaint device between 10jan2023 and 12jan2023.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 out of specification; however, there is no evidence of non-conforming devices 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 a manufacturing deficiency contributed to this event.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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