It was reported this was a procedure to treat a heavily calcified and moderately tortuous left anterior descending artery.An nc trek 2.50x15mm balloon delivery catheter (bdc) was inserted.However, while in the patient, it was observed dye started to leak from the shaft.Therefore, the bdc was removed and replaced with an nc trek 2.50x12mm.However, the same issue occurred.The device was removed and replaced with another same sized nc trek, but again, dye leaked from the shaft.The device was removed and replaced.The procedure was then successfully completed.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 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.The two additional nc trek devices are being filed under separate medwatch report numbers.
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