(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The product was not returned to abbott vascular for analysis.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.The investigation was unable to determine a conclusive cause for the reported shaft tear.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that an unspecified guide wire was advanced in the patient, and when a 6.0 x 120 mm armada 35 balloon catheter was placed over the guide wire, the wire came out of the mid shaft of the balloon catheter.Reportedly, a micro hole in the mid shaft was noted, but no leak.The balloon did not enter the patient.Another unspecified balloon catheter was advanced over the guide wire, and the procedure was successfully completed.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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