Exemption number e2019001.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 balloon rupture.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The nc traveler is currently not commercially available in the us; however, it is similar to a device sold in the us.
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It was reported that the procedure was to treat a moderately calcified, 90% stenosed, de novo lesion, in the left anterior descending coronary artery.The 3.0x15mm nc traveler rx balloon dilatation catheter (bdc) was advanced to the target lesion and during the first inflation to 12 atmospheres, the balloon ruptured.The bdc was removed without issue and the procedure was successfully completed with a non-abbott bdc.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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