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

Model Number	1012270-20
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported complaints appear to be related to operational context.There was no damage noted to the device during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that the balloon dilatation catheter (bdc) interacted with the moderately calcified anatomy resulting in the reported failure to advance.Upon further manipulation during attempts to advance the device, as difficulty was encountered, the shaft kinked and subsequently separated during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the left circumflex coronary artery with moderate calcification and 90% stenosis.The 2x20m mini trek balloon dilatation catheter (bdc) was attempted to be advanced but there was resistance due to the anatomy and the shaft kinked.Upon removal, the shaft separated once outside the anatomy.A non-abbott device was used to complete the procedure.There were no adverse patient effects and there was 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 and separation were 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.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported complaints appear to be related to circumstances of the procedure.There was no damage noted to the device during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that the balloon dilatation catheter (bdc) interacted with the moderately calcified anatomy resulting in the reported failure to advance.Upon further manipulation during attempts to advance the device, as difficulty was encountered, the shaft kinked and subsequently separated during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9: corrected device available for evaluation from no to yes h6: component code 4755 was removed h6: type of investigation code 4114 was removed.

• 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: 24309417
• Report Number: 2024168-2026-00562
• Device Sequence Number: 20150062
• Product Code: LOX
• UDI-Device Identifier: 08717648138164
• UDI-Public: (01)08717648138164(17)280229(10)50314G1
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 50314G1
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• 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