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

Model Number	1012270-20
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
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 upon opening the package of a 2.00x20mm mini trek rx balloon dilatation catheter, the shaft was observed to be kinked in 3 places.A new unspecified device was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.Return device analysis identified that the stylet and protective sheath could not be removed from the bdc.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported kinks were confirmed.Additionally, return device analysis noted that the protective sheath could not be removed from the balloon dilatation catheter (bdc).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 kinks could not be determined.The difficulty removing the protective sheath from the device during return analysis appears to be related to operational context.Returned device analysis noted three kinks noted in the dispenser coil, a kink in the protective sheath, and stylet located proximally from distal end of protective sheath and two kinks in the hypotube located distally from the distal end of strain relief.The stylet, protective sheath, balloon, and hypotube were kinked at same locations of the noted kink rings of dispenser coil when coiled.Potential factors that may contribute to kink damage to the bdc and dispenser coil include, but are not limited to, mishandling during manufacturing, during receiving/storage at the account, and/or handling during removal from packaging or preparation.In this case, a conclusive cause cannot be determined.Additionally, it was noted that the protective sheath could not be removed from the bdc, which likely resulted from the noted kinks on the sheath and stylet.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: MINI 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: 22196017
• Report Number: 2024168-2025-06075
• Device Sequence Number: 21139106
• Product Code: LOX
• UDI-Device Identifier: 08717648138164
• UDI-Public: (01)08717648138164(17)270731(10)40831G1
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/17/2025

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: 1012270-20
• Device Catalogue Number: 1012270-20
• Device Lot Number: 40831G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2024
• 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