(b)(4).Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: under precautions, "the catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction." the visual inspection of the returned device reported the device was returned for investigation.The catheter shaft was heavily dented 1.7 cm from the distal tip, and the reported split was located 4.5 cm from the distal tip.The shaft was close to being separated.No other damage was noted.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Due to the heavily dented shaft near the tip, it is possible that the procedure was difficult or the patient had a tortuous anatomy.As such, it is feasible to suggest that the split was caused by the device experiencing forces beyond its design.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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