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

Model Number	1012455-08
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
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 to treat an 80% stenosed lesion in the mid left anterior descending (mlad) artery with moderate calcification and moderate tortuosity.The 5x8mm nc trek balloon dilatation catheter (bdc) was attempted to be advanced to the target lesion, however, the bdc failed to advance due due to the anatomy.The shaft of the bdc became fractured during advancement; therefore, a balloon was used to assist with removal of the bdc.There was a delay in treatment due to the balloon fracture.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported complaints, unexpected medical intervention and delay to treatment appear to be related to circumstances of the procedure.It was reported that the balloon dilatation catheter (bdc) interacted with the moderately tortuous and moderately calcified anatomy resulting in the reported failure to advance.Upon further manipulation of the device, as difficulty was encountered, the shaft of the device broke.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: d9- device available for evaluation updated from yes to no.Correction: e3- occupation updated from na to physician.

• 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: 22470613
• Report Number: 2024168-2025-07096
• Device Sequence Number: 18166157
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: (01)08717648152139(17)270731(10)40814G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 40814G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown