Visual analysis was performed on the returned unit.The balloon material rupture was confirmed.The deflation problem, and difficult to remove were unable to be confirmed.Additionally, it was noted that the proximal balloon marker was loose and freely moving on the inner member.There was a separation on the inner member distal to the proximal balloon seal.The material at the noted separations of the inner and outer member was jagged.The separated portion of the balloon, inner and outer member was not returned.There was no other damage noted to the balloon dilatation catheter (bdc).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 of the reported lot revealed no other similar complaints.It should be noted that ifu, pta, armada 35 instructions for use (ifu) states: ¿perform the following steps to remove all air and verify the integrity of the pta catheter.1) fill an inflation device/syringe with a mixture of contrast medium and normal saline.2) remove protective tubing from the balloon.3) attach the inflation device/syringe to the connector of the balloon lumen.Hold the catheter with the distal tip pointing downwards.4) open the stopcock to the catheter; pull negative for 30 seconds; release to neutral for contrast fill.5) close the stopcock to the catheter; purge the inflation device/syringe of all air.6) repeat steps 4 through 6 until all air is expelled.7) leave the catheter under negative pressure until the balloon is at the target lesion site.The deviation to not perform preparation may have contributed to the material rupture, however, the likely cause is related to the calcified lesion.Based on the information provided, the balloon rupture and difficult to remove appear to be due to case circumstances.It is likely that the balloon rupture occurred due to interaction with the calcified lesion causing damage to the outer surface of the balloon material leading to the rupture and then the difficult to remove.A conclusive cause for the deflation issue could not be determined.The noted inner member separation, noted dislocated marker, and the reported addition therapy to attempt removal of system were due to the case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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