The device was returned for analysis.Visual inspection was performed on the returned device.The reported difficult to remove was confirmed.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 similar incidents from this lot.The investigation determined the reported difficult to remove appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The bmw guidewire referenced is filed under a separate medwatch report number.
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It was reported that the procedure was to treat a lesion in the moderately calcified, distal right coronary artery.The balance middle weight (bmw) guide wire and the 2.25x12mm xience sierra stent delivery system (sds) successfully crossed the target lesion.The sierra stent was implanted without issue.However, resistance was felt with the guide wire during removal.The guidewire and the sds were removed together as a single unit.A burr could be felt on the radiopaque tip of the guide wire.There was no clinically significant delay in the procedure and no adverse patient effect.No additional information was provided.
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