(b)(4).Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device 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.It was reported by the account that since resistance was met with an unspecified source during attempts to remove the device, it was decided to pull hard on the balloon catheter, when it was then noted that the shaft separated in two pieces within the guide catheter.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, it is likely that the violation of the ifu contributed to the reported separation as the device separated after force was applied.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device; however, the reported separation appears to be related to user error/operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
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It was reported that the procedure was to treat a left main artery.An nc trek balloon was advanced without issue to the target lesion.The balloon was inflated without issue although unknown inflations and atmospheres.The balloon was confirmed to be fully deflated before removal.During removal of the balloon, resistance was met with an unspecified source.At that point, it was decided to pull hard on the balloon catheter, when it was then noted that the shaft separated in two pieces within the guide catheter.Therefore, the devices were removed altogether as one unit without issue.Another balloon was used 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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