Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty advancing and removing the device over the guide wire was not 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 other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty advancing and removing the device from the guide wire.Factors that may contribute to the difficult advancing and removing the bdc from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, device placement technique, buildup of procedural contaminants in the guide wire lumen, guiding catheter support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, or damage to the distal shaft of the catheter.In this case, a conclusive cause for the reported difficulty could not be determined since the complaints could not be confirmed during return analysis.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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