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

Model Number	1012276-15
Medical Device Problem Codes	Deflation Problem (1149); Material Separation (1562); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a vein graft in the proximal obtuse marginal with a sharp takeoff which compromised guide support.The 3.5x15 mm trek balloon dilatation catheter (bdc) was prepped per the instructions for use (ifu) and 50/50 contrast was used.The balloon was inflated once to nominal pressure and the device had issues with remaining positioned in the lesion.The device was re-engaged and inflated again but it was noted the balloon deflated slowly.The material on the balloon buckled and the balloon was still slightly inflated when removed.There were no adverse patient effects and there was no clinically significant delay in the procedure.The procedure was completed with stenting of the lesion.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 bend and separation were confirmed.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.The reported material too soft/flexible could not be replicated in a testing environment as it was based on operational circumstances.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, a definitive cause for the reported deflation issue and material too soft/flexible could not be determined; however, the reported bend and separation appear to be related to operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 2981 was removed.
Event or Problem Description
Subsequent to the initially filed report, it was reported that the balloon was fully deflated when attempting to re-position, and the balloon had a slight bend in the catheter and separated after the second inflation.

• 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: 22383105
• Report Number: 2024168-2025-06824
• Device Sequence Number: 6979586
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: (01)08717648138577(17)271031(10)41112G1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 1012276-15
• Device Catalogue Number: 1012276-15
• Device Lot Number: 41112G1
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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 Age: 72 YR
• Patient Sex: Male