It was reported that when the advance 14 lp low profile balloon catheter was removed from its sterile package, the physician noticed that the balloon material was frayed, bubbled, and not smooth as it should be.The device did not make contact with the patient.The male patient was to receive intervention for critical limb ischemia in an unspecified leg.A new advance 14 lp low profile balloon catheter was used and the procedure was successfully completed.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.
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A review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed there were bubbles and small strands on the surface of the balloon.Additionally, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows 18 nonconforming events that could contribute to this failure mode; however, there is no evidence to suggest all items in this lot or similar devices, in house or in the field, are non conforming.It should be noted there was one other reported complaint for this lot number; however, for an issue which was not related to the reported failure mode in this case.Based on the information provided and the results of our investigation, the root cause has been found to be manufacturing related; however, appropriate measures have been initiated to address this failure mode.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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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