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

Model Number	1012274-12
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.There were no leaks noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, based on the reported information, resistance was noted during advancement due to interaction with the lesion calcification.It is likely that the balloon material was damaged during advancement resulting in rupture during inflation.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed de novo lesion in the distal left anterior descending (dlad) artery with heavy calcification and mild tortuosity.The 3x12mm trek balloon dilatation catheter (bdc) was advanced with resistance due to the anatomy to the target lesion.Then the balloon was inflated to 8 atmospheres (atm); however, the balloon ruptured during the first inflation.Therefore, the bdc was removed from the patient and the procedure was completed with an unspecified trek balloon.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another trek balloon was used to continue the procedure.No additional information was provided.

• Brand Name: 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: 21574588
• Report Number: 2024168-2025-02489
• Device Sequence Number: 12949446
• Product Code: LOX
• UDI-Device Identifier: 08717648138423
• UDI-Public: (01)08717648138423(17)270630(10)40726G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103110
• 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
• Report Date (Section B): 03/11/2025

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: 1012274-12
• Device Catalogue Number: 1012274-12
• Device Lot Number: 40726G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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