It was reported that this was a procedure to treat a lesion in the left circumflex artery.A 4.50 x 15mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion.However, after the final inflation was completed, the balloon could only partially deflate.An attempt was made to retract the bdc into the guiding catheter when the balloon became stuck and separated.The separated portion of the balloon remained wedged inside the guiding catheter.Therefore, the bdc was removed with the guiding catheter and the separated portion as a single unit.The procedure continued with a new bdc and new guiding catheter to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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The device was returned.Visual inspections were performed on the returned device.The reported separation was confirmed.The reported deflation issue and difficulty removing the device from the guiding catheter 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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device and separation appear 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.Na.
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