(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Use after damage.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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(b)(4).Evaluation summary: a visual and functional inspection was performed on the retuned device.The reported inflation issue, material rupture and balloon damage were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.It should be noted that armada 14 catheter, instructions for use (ifu) states: carefully inspect the catheter prior to use to verify that it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.In this case, it is likely the ifu deviation contributed to the reported difficulties of balloon rupture and deflation issue.The investigation determined that the reported difficulties of device used after rupture and balloon rupture appear to be related to user error as the device was used after damages were noted.The reported/noted inflation issue, balloon damage, inner/outer member and shaft damages appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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