It was reported that during preparation of the 4.0x12 nc trek balloon dilatation catheter (bdc), after flushing, the sheath was attempted to be removed however resistance was met and the balloon separated and came off with the sheath.The device was flushed per instructions for use (ifu) and the device was prepared prior to removing the protective sheath/stylet removal.Another same size nc trek bdc was used to complete the procedure.There was no device use or patient involvement.There was no clinically significant delay in the procedure.No additional information was provided.
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H6- medical device problem code 2017 - incorrect prep visual and dimensional inspections were performed on the returned device.The reported separation was confirmed.The reported difficulty removing the protective sheath could not be replicated in a testing environment since the sheath component was not returned for analysis.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.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath; however, the reported separation appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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