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

Model Number	2078175
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in an unknown vessel.A 300cm ht command guidewire (gw) was used with a non-abbott laser atherectomy device; however during the procedure the wire was noted to break in one location and completely separate in another location.The gw was removed and the separation portion were received.There were no adverse patient sequela nor clinical delay.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.
Event or Problem Description
Subsequent the initially filed report, additional information was received and it was noted that the procedure was to treat a mildly calcified and tortuous lesion in the left superficial femoral artery (sfa).Resistance was noted when attempting to remove the guide wire from the laser atherectomy device and slight force was applied.The guidewire was noted to break but was held together by the coils, and the laser atherectomy device, and guide wire were pulled into the sheath where they all were removed as a single unit from the anatomy.At this point, the physician was able to rewire the vessel, perform percutaneous transluminal angioplasty (pta), and complete the proceed as originally intended to complete the procedure.There were no adverse patient effects nor clinical delay.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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, a definitive cause for the reported issue could not be determined.Factors that may contribute to difficult to remove include, but are not limited to, outer diameter of the guide wire, challenging anatomy, device support, buildup of procedural contaminants, user technique, and/or damage to the guide wire which likely led to the reported guide wire break.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.B1 correction: adverse event removed b2 correction: required intervention removed d4 correction: lot number updated from unknown to 5041071 h1 correction: serious injury removed.

• Brand Name: HI-TORQUE COMMAND
• 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: 22501481
• Report Number: 2024168-2025-07241
• Device Sequence Number: 12512741
• Product Code: DQX
• UDI-Device Identifier: 08717648176685
• UDI-Public: (01)08717648176685(11)250410(17)270331(10)5041071
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122573
• 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): 08/28/2025

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: 2078175
• Device Catalogue Number: 2078175
• Device Lot Number: 5041071
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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: LASER ATHERECTOMY CATHETER: PHILIPS LASER CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown