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

Model Number	1009664
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
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.
Event or Problem Description
It was reported in a general comment that the balance middleweight universal ii guide wire broke but did not separate into two pieces during use.The device was removed when it was noted.There were no reported adverse patient effects and there was no reported 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.Based on the information provided, a definitive cause for the reported issue could not be determined.It is possible that the guide wire became damaged during advancement.As this is base off a general comment no further investigation can be made.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: 23425613
• Report Number: 2024168-2025-11284
• Device Sequence Number: 9854242
• Product Code: DQX
• UDI-Device Identifier: 08717648118715
• UDI-Public: (01)08717648118715(11)240205(17)260131(10)4020572
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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,Followup
• Report Date (Section B): 11/12/2025

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 Expiration Date: 01/31/2026
• Device Model Number: 1009664
• Device Catalogue Number: 1009664
• Device Lot Number: 4020572
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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
• Patient Sex: Unknown