It was reported that the procedure was performed to treat a lesion in the left anterior descending artery.A 3.25x12mm nc trek balloon dilatation catheter (bdc) was being advanced; however, resistance with the anatomy was felt.Excessive force was used during insertion and it was noted that the shaft kinked in multiple areas.Additionally, the proximal shaft separated at the site of the kink outside the patient anatomy.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual and dimensional inspections were performed on the returned device.The reported kink and separations were confirmed.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It should be noted that the coronary dilatation catheters (cdc), nc 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 violation of the ifu contributed to the reported kink and separation as the device kinked and separated after force was applied.The investigation determined the reported failure to advance appears to be related to operational context; however, the reported kink and separations appear to be related to user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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