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

Model Number	1009664
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat an 80% stenosed lesion in the left anterior descending (lad) artery.The ht bmw universal ii 190cm guide wire (gw)was used in the procedure with an unspecified balloon dilatation catheter (bdc); however, when attempting to remove the bdc, the gw became stuck to the inner lumen of the bdc.Therefore, the bdc and gw had to be removed as a single unit.It was noted that the outer diameter of the gw (polymer coating area) seems to quickly increase due to the body temperature and adheres to the inner lumen of the balloon.The procedure was successfully completed with a new unspecified balloon catheter and an unspecified guidewire.There were no adverse patient effects and no clinically significant delay in the procedure.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 provided, a definitive cause for the reported issue could not be determined.It is possible the wire was damaged during advancement.The polymer coating would not be affected by body temperature to affect its od.The irregular appearance to the polymer coating, or to the coils could affect od of the wire.The increased od would cause an interaction with the id of the catheter inducing the difficult to remove.It is unknown if the irregular appearance to the polymer was a cause, is an artifact of, or was exasperated due to device interaction.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 24322982
• Report Number: 2024168-2026-00600
• Device Sequence Number: 18527107
• 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): 02/12/2026

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: 01/22/2026
• Initial Report FDA Received Date: 02/12/2026
• 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
• Patient Sex: Unknown