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

Model Number	1012274-12
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left circumflex (lcx) artery with moderate calcification and moderate tortuosity.After pre-dilatation with a semi-compliant balloon, the 3x12mm trek balloon dilatation catheter (bdc) was being advanced with resistance with the guide catheter and force was applied against the resistance.The shaft of the bdc became kinked and then separated.The bdc was abe to be simply withdrawn without issue.A non-abbott semi-compliant balloon was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.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.H6: device code 2017, against resistance.
Additional Manufacturer Narrative
Visual inspection, functional testing, and dimensional analysis were performed on the returned device.The reported kink and separation were confirmed.The reported difficulty advancing the device 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 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 difficulty advancing the device could not be determined; however, the reported kink and shaft separation appear to be related to user error and/or operational context.In this case, it is likely that the applied forced against the reported resistance resulted in the reported kink and shaft separation.Possible factors which may contribute to resistance with the guiding catheter include, but are not limited to, manufacturing, damage to the guiding catheter, or procedural technique (devices not properly supported or coaxially aligned).In this case, a conclusive cause for the reported difficulty advancing the device could not be determined.Additionally, it was reported that force was applied to the device, as resistance was encountered, and the shaft became kinked and ultimately separated.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: 22177306
• Report Number: 2024168-2025-05967
• Device Sequence Number: 7818618
• Product Code: LOX
• UDI-Device Identifier: 08717648138423
• UDI-Public: (01)08717648138423(17)270228(10)40313G1
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 08/14/2025

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: 40313G1
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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