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

Model Number	1012276-30
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending artery.The 3.5x30mm trek rx balloon dilatation catheter (bdc) was inflated and used without issues.The bdc was deflated and an attempt to remove it was made; however, resistance with the anatomy was felt and the shaft separated from the hypotube.The bdc and the separation were removed as a single unit with other non-abbott devices.The procedure was successfully completed with a new 3.5x30mm trek rx bdc.There were no adverse patient effects and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Attachment medwatch report #mw5183316.
Event or Problem Description
Subsequent to the initial report being filed, a medwatch report was received stating the following: during pci (percutaneous coronary intervention), as ptca (percutaneous transluminal coronary angioplasty) balloon was being removed from lad (left anterior descending), balloon shaft broke with the balloon at end of guide.Dr (b)(6) removed guide, balloon, and wire as one unit successfully.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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.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 preparation or during successful use in the anatomy, 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 patient¿s anatomy during removal, such that difficulty was encountered and subsequently the shaft separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: b6 - full date added correction: d9 - device available for evaluation: updated from yes to no medwatch attached.

• 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: 24416586
• Report Number: 2024168-2026-00731
• Device Sequence Number: 5987912
• Product Code: LOX
• UDI-Device Identifier: 08717648138607
• UDI-Public: (01)08717648138607(17)270731(10)40807G1
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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: 1012276-30
• Device Catalogue Number: 1012276-30
• Device Lot Number: 40807G1
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 04/07/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSX 6 FR MACH CLS3.5 GUIDE CATHETER.; RUNTRHOUGH GUIDE WIRE.
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 137 KG
• Patient Race: Black Or African American