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

Model Number	1001782
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a highly calcified lesion in the right peroneal artery.The bmw guide wire was advanced however failed to cross the lesion.The guide wire was removed and set aside.Later in the procedure the guide wire was advanced again with a catheter however the physician felt an odd response from the guide wire and noticed the guide wire had separated inside the catheter.The catheter was removed with both pieces of the guide wire inside.Another bmw guide wire was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported material separation was confirmed.The reported difficult to advance the catheter over the guide wire was not confirmed due to the condition of the device with a material separation.The reported failure to advance in the anatomy could not be confirmed as the exact conditions encountered by the device during the procedure could not be replicated in a testing environment.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 provided and the observations from the returned analysis, the investigation determined that the reported issues appear to be related to circumstances of the procedure.In this case, the procedure was to treat a highly calcified lesion which likely contributed to the reported failure to advance which likely led to the reported difficulty advancing the catheter over the guide wire, material separation and observed bent tip.The observed scratched teflon coating was not reported which likely occurred due to 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.

• 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: 22358049
• Report Number: 2024168-2025-06685
• Device Sequence Number: 8052863
• Product Code: DQX
• UDI-Device Identifier: 08717648013843
• UDI-Public: (01)08717648013843(11)240820(17)260731(10)4082071
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/12/2025

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: 07/31/2026
• Device Model Number: 1001782
• Device Catalogue Number: 1001782
• Device Lot Number: 4082071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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