The device was not returned for evaluation.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The traveler rx device is currently not commercially available in the us; however, it is similar to a device sold in the us.
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56it was reported that the procedure was to treat a moderately tortuous, 90% stenosed, de novo lesion in the left circumflex artery.The 2.25x15mm traveler rx balloon dilatation catheter (bdc) was advanced to the target lesion, ¿slipped once¿ distally around 5 atmospheres (atm) and inflated slowly one time to 8 atm, for 5 seconds, but the angiography did not show that the balloon was inflated.The bdc was removed, and a balloon rupture was confirmed.Another bdc performed dilatation, and a xience stent was implanted to successfully complete 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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