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

Model Number	1012270-30
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a 2.00x30mm mini trek rx balloon dilatation catheter (bdc) was noted to be twisted in the packaging.A new mini trek rx bdc was used to complete the procedure.There was no device use or patient involvement, and no clinically significant delay in the procedure.Subsequently, returned device analysis observed the bdc inner and outer membrane separated.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported damage (twisting) was confirmed.Additionally, the returned device was returned with the inner and outer member separated.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 damage (twisting) and the noted inner and outer member separation could not be determined.Return device analysis note that outer member was smashed distally adjacent to the support skive/wire/bayonet, which is likely what was reported as twisted.Additionally, the returned device was returned with the inner and outer member separated.The material at both separations was jagged, which suggests that the separation may be related to tensile overload (material stress/fatigue).In this case, it is possible that the balloon catheter was inadvertently mishandled during unpackaging at the procedure, resulting in the reported damage (twisting) and noted separation of the inner and outer member, as the device revealed signs of handling.A conclusive cause cannot be determined since it is unclear when the damage and separation occurred.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: 23361321
• Report Number: 2024168-2025-11194
• Device Sequence Number: 8965108
• Product Code: LOX
• UDI-Device Identifier: 08717648138188
• UDI-Public: (01)08717648138188(17)280331(10)50403G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 1012270-30
• Device Catalogue Number: 1012270-30
• Device Lot Number: 50403G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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