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

Model Number	1012270-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 90% de novo lesion in an unspecified artery with moderate calcification and heavy tortuosity.For pre-dilatation, the 2x15mm mini trek balloon dilatation catheter (bdc) was advanced to the target lesion with resistance due to the anatomy; however, the bdc was ultimately able to cross the lesion.After pre-dilatation, the bdc was withdrawn for further imaging.The bdc was re-advanced for further dilatation, but the bdc was not able to pass smoothly through the guide catheter.Then during removal of the bdc, resistance was also noted with the guide catheter and the shaft separated.The bdc was able to be removed from the patient by slightly withdrawing the guide wire which the separated portion became visible and was able to be withdrawn.The procedure was continued with a 2.5x12 trek bdc followed by stent implantation.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
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 difficulty advancing the device into the anatomy appears to be related to operational context.The investigation was unable to determine a conclusive cause for the reported difficulty advancing and removing the device into the guiding catheter.The investigation determined the reported separation appears to be related to user error/operational context.It was reported by the account that the balloon dilatation catheter (bdc) interacted with the heavily tortuous and moderately calcified anatomy resulting in the reported difficulty advancing the device.Possible factors which may contribute to resistance with the guiding catheter during advancement include, but are not limited to, manufacturing, damage to the guiding catheter, or procedural technique (devices not properly supported or coaxially aligned).Possible factors that can contribute to difficult to remove/resistance with the guiding catheter post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends or procedural technique.Furthermore, it is likely that the device was inadvertently mishandled during advancement and/or removal, as resistance was encountered, such that the shaft kinked, and upon furth manipulation and applied force the shaft ultimately separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017 - against resistance.

• 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: 24448502
• Report Number: 2024168-2026-00785
• Device Sequence Number: 10372946
• Product Code: LOX
• UDI-Device Identifier: 08717648138157
• UDI-Public: (01)08717648138157(17)280831(10)50905G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/25/2026

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: 1012270-15
• Device Catalogue Number: 1012270-15
• Device Lot Number: 50905G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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