It was reported that this was a procedure to treat a lesion with heavy calcification and no tortuosity in the proximal mid left anterior descending (lad) coronary artery.Atherectomy was performed and then a 3.5 x 20 mm voyager nc balloon catheter was advanced to the target lesion without resistance.The balloon was inflated three times to 16 atmospheres.The balloon deflated normally but re-wrap of the balloon was not normal.The balloon deflated like a pancake; therefore, there was difficulty removing the balloon through the guiding catheter.The guiding catheter had to be removed first, then the voyager nc was removed without issue.A stent was implanted successfully completing the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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Visual and functional inspections were performed on the returned device.The reported failure to fold cold not be confirmed.The reported difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.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 failure to fold however, the reported difficulty removing the device from the guiding catheter appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D4 - lot no updated, expiration date updated h4 - device manufacture date updated.
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