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

Model Number	1012274-20
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
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 that the procedure was to treat a heavily calcified, heavily tortuous mid right coronary artery.During advancement of a 3.00x20mm trek balloon delivery catheter (bdc), resistance was noted due to anatomy and the bdc shaft was noted to be kinked and fractured however; still in one piece.Another 3.00x20mm trek rx bdc was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and dimensional analysis were performed on the returned device.The reported kink was confirmed.The reported failure to advance 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.The complaint information and analysis of the returned device were reviewed.Analysis of the returned product indicated the balloon dilatation catheter (bdc) was returned with blood in the tightly folded balloon folds, in the guidewire lumen and with contrast on the device, consistent with preparation of the device and advancement in the anatomy.The inner and outer member were kinked in two locations, distal to the guidewire exit notch, confirming the reported complaint.There were bends on the hypotube likely due to handling during packaging to return.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported complaints appear to be related to operational context.It was reported by the account that the bdc interacted with the heavily calcified and heavily tortuous anatomy resulting in the reported failure to advance and subsequently the shaft became kinked, as difficulty was encountered.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 correction: medical device problem code 1069 removed.
Event or Problem Description
Subsequently, after the initial was filed it was noted that the shaft was only kinked.No additional information was provided.

• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20967318
• Report Number: 2024168-2024-14973
• Device Sequence Number: 4032688
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: (01)08717648138447(17)270831(10)40924G1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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: 1012274-20
• Device Catalogue Number: 1012274-20
• 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): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/31/2025
• 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: Male
• Patient Weight: 84 KG