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

Model Number	1012274-12
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
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.B3- estimated date the additional devices referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported as a general comment that the reference size indicated on the hub of the rx trek balloon dilatation catheter was difficult to see.During a procedure recently, he had on his table three balloons with different sizes and references.Per the physician, he had difficulty distinguishing the references and he could have made a mistake and it could have had consequences for the patient if the cardiologist had used a 4.0mm balloon in a 2.5mm artery.No additional information was provided.
Event or Problem Description
It was reported as a general comment that the reference size indicated on the hub of the rx trek balloon dilatation catheter was difficult to see.During a procedure recently, he had on his table three balloons with different sizes and references.Per the physician, he had difficulty distinguishing the references and he could have made a mistake and it could have had consequences for the patient if the cardiologist had used a 4.0mm balloon in a 2.5mm artery.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.The investigation determined there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device and the reported difficulty appears to be related to operational context.It was reported as a general comment that the reference size indicated on the hub of the rx trek balloon dilatation catheter (bdc) was difficult to see.It is possible that the lighting in the operating room and/or position in which the sidearm is held can contribute to the reported difficulty.There was no indication of incorrect information on the device, no adverse event or a specific device failure was reported.This event is to capture a general suggestion / product feedback from the physician.

• 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 UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23121235
• Report Number: 2024168-2025-10154
• Device Sequence Number: 7442677
• Product Code: LOX
• UDI-Device Identifier: 08717648138423
• UDI-Public: (01)08717648138423(17)280430(10)50522G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 1012274-12
• Device Catalogue Number: 1012274-12
• Device Lot Number: 50522G1
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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