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

Model Number	1012279-12
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in ostial right coronary artery (rca) with heavy calcification and mild tortuosity.The 4.5x12mm trek balloon dilatation catheter (bdc) was advanced to the target lesion and the balloon was inflated to nominal pressure; however, the balloon ruptured during the first inflation and piece of the balloon separated.A stent was implanted to embed the separated piece of balloon.The stent was post dilated with a nc trek neo balloon to complete the procedure.There was no adverse patient sequela and no clinically significant delay was reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed; however, the reported balloon rupture could not be replicated in a testing environment due to the condition of the returned device.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.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported balloon rupture, separation, unexpected medical intervention and device embedded in tissue or plaque appear to be related to circumstances of the procedure.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the heavily calcified anatomy resulting in the reported balloon rupture.The balloon rupture likely did not allow the balloon to refold properly resulting in the material interacting with the patient anatomy and/or accessory device and subsequently lead to the reported separation during manipulation and/or removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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 UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22809597
• Report Number: 2024168-2025-08492
• Device Sequence Number: 18092310
• Product Code: LOX
• UDI-Device Identifier: 08717648138751
• UDI-Public: (01)08717648138751(17)270531(10)40605G1
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K180040
• 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): 10/28/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012279-12
• Device Catalogue Number: 1012279-12
• Device Lot Number: 40605G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEMAX INTERVENTIONAL SET INDEFLATER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown