MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE BALANCE MIDDLEWEIGHT¿; WIRE, GUIDE, CATHETER

Model Number	1009664
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
Type of Reportable Event	Malfunction
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 of specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined.It is possible the wire was damaged during use with the stent catheter which caused a change in the od of the guide wire.A larger od would cause an interaction with the ballon catheter inducing the difficult to advance and difficult to remove.It is unknown if the reported deformation on the jacket was the cause or a result of the guide wire being removed post procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the procedure was to treat a mildly calcified and tortuous lesion in the mid left anterior descending artery.The bmw universal ii guide wire was advanced to the target lesion however after stent implantation, resistance occurred during the insertion of the nc balloon catheter and the devices adhered together.Since the balloon catheter could not be removed, both devices were removed together.Outside the anatomy the devices were able to be separated however damage was noted to the polymer of the guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT¿
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 24240064
• Report Number: 2024168-2026-00443
• Device Sequence Number: 8980972
• Product Code: DQX
• UDI-Device Identifier: 08717648118715
• UDI-Public: (01)08717648118715(11)250527(17)270430(10)5052772
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K152709
• 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
• Report Date (Section B): 02/02/2026

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: 1009664
• Device Catalogue Number: 1009664
• Device Lot Number: 5052772
• 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: 01/26/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER.
• Patient Sex: Unknown