MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012447-15
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and mildly tortuous lesion in the left anterior descending (lad) artery.After a 2.50x15mm nc trek balloon dilatation catheter (bdc) was prepared with no noted issues, it was advanced to the lesion and was attempted to be used for vessel dilatation.However, the bdc was noted to fail to inflate, and after the bdc was removed a break within the inner member of the shaft was noted.The bdc was removed and replaced with another abbott balloon and the procedure was completed.There were no adverse patient effects nor clinical delay reported.No additional information was provided.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and mildly tortuous lesion in the left anterior descending (lad) artery.After a 2.50x15mm nc trek balloon dilatation catheter (bdc) was prepared with no noted issues, it was advanced to the lesion and was attempted to be used for vessel dilatation.However, the bdc was noted to fail to inflate, and after the bdc was removed a break within the inner member of the shaft was noted.The bdc was removed and replaced with another abbott balloon and the procedure was completed.There were no adverse patient effects nor clinical delay reported.Subsequent to the initially reported information the device was received and the analysis revealed a separation of the hypotube at 1mm distally from the distal end of single arm.Both proximal and distal segments were returned.The account could not confirm nor deny the noted damages found in the product return, due to the lack of recollection of the details on the event.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and functional testing were performed on the returned device.The reported break/separation was confirmed.The reported inflation issue was not confirmed during returned device analysis; however, it is likely that the noted break/separation is what caused the reported inflation issue.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned device analysis, the investigation determined that the reported break/separation and inflation issue appear to be related to operational context.Returned device analysis noted a separation of the hypotube distally from the distal end of the single arm, which is likely what the account perceived as the reported break.The separation ends were oval and jagged which can indicate the hypotube was kinked and then separated.The proximal segment was still fixed in the distal end of the single arm inside the strain relief which likely gave the impression of a break and not a full separation.There was no damage or leak noted to the balloon dilatation catheter (bdc) during the inspection or preparation prior to use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that that the bdc was inadvertently mishandled during advancement such that the hypotube kinked, separated, gave the impression that the strain relief broke and subsequently resulted in the reported inflation issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21483488
• Report Number: 2024168-2025-02180
• Device Sequence Number: 8422913
• Product Code: LOX
• UDI-Device Identifier: 08717648151767
• UDI-Public: (01)08717648151767(17)270531(10)40620G2
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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 Model Number: 1012447-15
• Device Catalogue Number: 1012447-15
• Device Lot Number: 40620G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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