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

Model Number	1012405-06
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
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 during inflation of the 2.5x6 mm trek balloon dilatation catheter, the balloon ruptured.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, functional testing, and scanning electron microscopy (sem) analysis were performed on the returned device.The reported balloon rupture was not confirmed.Return device analysis noted a tear in the inner and outer member on the distal shaft.Fluid leaked from the noted tear in the inner and outer member.In this case, it is likely that the noted tears on the inner and outer member is what the account perceived as the reported rupture since the device leaked and would not hold pressure.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.The balloon was sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the outer member leak may be attributed to mechanical damage to the outer surface.Mechanically pinched material, damage and tearing were documented at the leak edges.Partial tearing on the inner surface adjacent to the leak was also observed.The inner member exhibited pinching, damage, delaminated material and tearing.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported complaint, noted leak and tear in the inner and outer member could not be determined.In this case, it is possible that the device was inadvertently mishandled and/or interacted with lab equipment and/or accessory device during the procedure such that the inner and outer member became damaged (torn), which resulted in the noted leak and subsequently gave the impression of a balloon rupture; however, a conclusive cause cannot be determined since limited information was provided.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: 22364462
• Report Number: 2024168-2025-06706
• Device Sequence Number: 18537489
• Product Code: LOX
• UDI-Device Identifier: 08717648153952
• UDI-Public: (01)08717648153952(17)270831(10)40924G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 1012405-06
• Device Catalogue Number: 1012405-06
• Device Lot Number: 40924G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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