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

Model Number	1009664J
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
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 de novo lesion in the circumflex (cx) artery with moderate calcification and mild tortuosity.The ht bmw universal ii 190cm j guide wire (gw) was attempted to be used in the procedure; however, difficulty was noted during advancement with the anatomy and the inner core of the gw seemed broken.This led to poor maneuverability of the gw and loss of support.Therefore, the gw was removed from the patient.Another ht bmw universal gw was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.It was reported that the guide wire interacted with the patient¿s moderately calcified and mildly tortuous lesion, resulting in resistance during advancement.Additionally, it was reported that the guide wire had broken, resulting in loss of support (material too soft / flexible).In this case, it is possible that manipulation of the wire, when resistance was encountered, contributed to the break.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.Correction to d9 - device available for evaluation updated from yes to no.

• 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: 21943565
• Report Number: 2024168-2025-04537
• Device Sequence Number: 8799787
• Product Code: DQX
• UDI-Device Identifier: 08717648118753
• UDI-Public: (01)08717648118753(11)240502(17)260430(10)4050271
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 04/30/2026
• Device Model Number: 1009664J
• Device Catalogue Number: 1009664J
• Device Lot Number: 4050271
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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