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

Model Number	1009660
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	06/05/2025
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 the procedure was to treat a mildly calcified lesion in the left anterior descending artery.The ht command 14 guide wire was advanced with a 2.50x15mm balloon catheter to the target lesion.After inflating the balloon to 18 atmospheres, the guide wire stuck to the balloon catheter and the tip separated.The separated guide wire was removed with the balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported guide wire separation was confirmed.The reported resistance with the balloon catheter was not confirmed due to the condition of the returned separated guide wire.Production record and corrective and preventive 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, a definitive cause for the reported difficulty could not be determined.Factors that may contribute to resistance with the balloon catheter include, but are not limited to, inner diameter of the catheter, device support, buildup procedural contaminants, challenging anatomy, user technique and/or damage to the catheter and guide wire which likely led to the reported material separation and observed damages to the guide wire.The observed scraped teflon coating was not reported which likely occurred due to an interaction with the torque device being tight against the guide wire.Based on the results of the complaint investigation, there is no indication a product quality issue with respect to manufacture, design or labeling of the device.D4: model, catalog updated from 2078173 to 1009660.
Event or Problem Description
It was reported the procedure was to treat a mildly calcified lesion in the left anterior descending artery.The ht command 14 guide wire was advanced with a 2.50x15mm balloon catheter to the target lesion.After inflating the balloon to 18 atmospheres, the guide wire stuck to the balloon catheter and the tip separated.The separated guide wire was removed with the balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Subsequent to the initially filed medwatch report, additional information was provided.It was reported the bmw universal guide wire was used in the procedure, not a command 14.

• 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: 22435315
• Report Number: 2024168-2025-06951
• Device Sequence Number: 3153001
• Product Code: DQX
• UDI-Device Identifier: 08717648014338
• UDI-Public: (01)08717648014338(11)250401(17)270331(10)5040171
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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 Model Number: 1009660
• Device Catalogue Number: 1009660
• Device Lot Number: 5040171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: 2.50X15 BALLOON CATHETER.
• Patient Sex: Unknown