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

Model Number	1012448-15
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
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 during preparation of the 2.75x15mm nc trek balloon dilatation catheter it was observed that the shaft was kinked and attempt was made to straight out the device; however, separated at the shaft.Another device was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported kink and separation were confirmed.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 analysis, the investigation determined that the reported complaints appear to be related to operational context.There was no damage noted to the balloon dilatation catheter (bdc) during the inspection prior to preparation/use 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 preparation such that the shaft became kinked and upon further manipulation the shaft ultimately separated.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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20752435
• Report Number: 2024168-2024-13838
• Device Sequence Number: 8137247
• Product Code: LOX
• UDI-Device Identifier: 08717648151828
• UDI-Public: (01)08717648151828(17)270228(10)40301G1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110134
• 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): 01/13/2025

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: 1012448-15
• Device Catalogue Number: 1012448-15
• Device Lot Number: 40301G1
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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