(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual inspection was performed on the retuned device and the reported balloon rewrap/folded issue was confirmed.The reported difficulty to remove the device from a guiding catheter could not be confirmed due to the returned condition of the balloon.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported balloon refold/rewrap issue.Although a conclusive cause for the reported balloon fold issue could not be identified, the reported difficulty to remove through the introducer sheath appears to be related to circumstances of the procedure as the winged/flat balloon did not properly fit through the distal end of the guiding catheter during retraction causing resistance.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 the procedure was performed to treat a lesion in the left main coronary artery with no tortuosity and mild calcification.Following deployment of an unspecified stent, a 4.00 x 15 mm nc trek rx balloon dilatation catheter was advanced for successful post stent dilatation.Despite fully deflating, the balloon of the bdc failed to rewrap tightly and met resistance with the unspecified guide catheter on removal from the anatomy.Further inflation and deflation of the balloon was attempted; however, the rewrap problems remained and the bdc and guide catheter had to be removed as a single unit.A new guide catheter was placed to successfully continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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