MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012447-15
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous, 90% stenosed lesion in the mid left anterior descending (mlad) artery.During advancement, the hub of the 2.50x15mm nc trek balloon dilatation catheter (bdc) separated into two pieces without any noted resistance.The device was removed without issue and with nothing remaining in the patient.There was no reported adverse patient effect and no clinically significant delays in the procedure.A 2.5x15mm nc trek device used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the similar incidents/complaints review, there is no indication of a lot specific product quality issue.The investigation determined the reported separation appears to be related to operational context.There was no damage noted to the device during the inspection prior to use or during inflation of the device in the patient anatomy, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the bdc was inadvertently mishandled during advancement and/or initial inflation of the balloon such that the hypotube became kinked and during further manipulation of the device it ultimately separated.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was received: the 2.50x15mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion and inflated one time to 12 atmospheres (atm) when the hypotube separated into two pieces without any noted resistance.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16392879
• Report Number: 2024168-2023-01599
• Device Sequence Number: 5722139
• Product Code: LOX
• UDI-Device Identifier: 08717648151767
• UDI-Public: 08717648151767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 1012447-15
• Device Catalogue Number: 1012447-15
• Device Lot Number: 20408G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown