Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty removing the protective sheath 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 other incidents and/or complaints from this lot.It was reported that the bdc was prepped prior to the sheath being removed.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) states: complete the following steps to prepare the nc trek rx coronary dilatation catheter for use: slide the protective sheath off the balloon prior to performing air aspiration.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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