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

Model Number	1012272-20
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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 the procedure was to treat a lesion in the left anterior descending (lad) artery.The 2.5x20m trek balloon dilatation catheter (bdc) was attempted to be inflated; however, although the device was attempted to be inflated twice, no pressure was noted and the balloon failed to inflate.Therefore, the bdc was removed from patient.A non-abbott balloon followed by stent implantation was performed to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.Return device analysis found a leak in the outer member of the 2.5x20m trek balloon dilatation catheter (bdc) at 3 atmospheres.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 inflation issue was confirmed.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 inflation issue could not be determined.There was no damage or leak noted during preparation or during inspection prior to use, which suggests a product quality issue did not contribute to the reported difficulties.Return device analysis noted a leak in the outer member of the bdc.Sem analysis determined the outer member leak may be attributed to mechanical damage to the outer surface.In this case, it is possible that the device was inadvertently mishandled during preparation and/or advancement of the device such that the shaft became damaged, leaked and subsequently resulted in the reported inflation issue; however, a conclusive cause cannot be determined.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: 21423781
• Report Number: 2024168-2025-01910
• Device Sequence Number: 7642467
• Product Code: LOX
• UDI-Device Identifier: 08717648138300
• UDI-Public: (01)08717648138300(17)270531(10)40621G2
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 03/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012272-20
• Device Catalogue Number: 1012272-20
• Device Lot Number: 40621G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic
• Patient Race: White