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

Model Number	1012273-15
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
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 the procedure was to treat an unspecified coronary artery.The 2.75x15 mm trek balloon dilatation catheter (bdc) was attempted to be inflated; however, the balloon did not inflate and there was back flow of blood into the inflator [rupture].Upon removal of the device from the guiding catheter, the hypotube became separated.The guiding catheter was removed and the separated pieces were recovered.A new guiding catheter and balloon were 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 functional testing were performed on the returned device.The reported separation was confirmed.The reported balloon rupture was not confirmed; however, it is likely that the separation is what was perceived as the balloon rupture since the balloon would not inflate and backflow of blood was reported in the inflation device.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 that the reported balloon rupture and separation appear to be related to operational context.Return device analysis noted that the balloon was tightly folded, which indicates that the balloon did not inflate.The reported balloon rupture could not be confirmed.The hypotube was separated, distal to the distal end of the strain relief tubing.The hypotube fracture faces were oval shaped, which can indicate the hypotube was kinked and then separated.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.Based on the condition of the returned device, it is likely that the trek balloon dilatation catheter (bdc) was inadvertently mishandled and/or interacted with an accessory device and/or the patient¿s anatomy during advancement, such that the shaft kinked and separated.The separation gave the impression of a balloon rupture since the balloon would not inflate and backflow of blood was reported in the inflation device.Upon removal of the device the separation was confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 23616771
• Report Number: 2024168-2025-11689
• Device Sequence Number: 15695334
• Product Code: LOX
• UDI-Device Identifier: 08717648138362
• UDI-Public: (01)08717648138362(17)280430(10)50528G1
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 1012273-15
• Device Catalogue Number: 1012273-15
• Device Lot Number: 50528G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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