A visual inspection was performed on the returned device.The reported separation was confirmed.The reported deflation issue and 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 that force had to be applied to remove the bdc as there was difficulty deflating the balloon and resistance with the guiding catheter was encountered and subsequently the device separated.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use (ifu) 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 ifu violation contributed to the reported separation.The investigation was unable to determine a conclusive cause for the reported deflation issue.However, factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.The reported difficulty removing the device appears to be related to circumstances of the procedure as it is possible that the larger profile of the 5.00 mm balloon and the reported deflation issue contributed to the resistance met with the guiding catheter during removal.Additionally, the reported separation appears to be related to user error/operational context as force had to be use to remove the device given the clinical situation.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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