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

Model Number	1013730
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	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa).The hi-torque (ht) command 18 st guidewire was advanced without issues; however, upon removal got stuck with a micro dilator and was removed as a single unit.The guidewire was noted to have the polymer separated but remains on the the device and nothing remained in the anatomy.There was no adverse patient effect and there was 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 polymer coating separation was confirmed.The reported difficult to remove was not confirmed due to the condition of the returned device with the observed polymer separation.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, a definitive cause or the reported issue could not be determined.Factors that may contribute to difficult to remove from a micro catheter include, but are not limited to, inner diameter of the catheter, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the guide wire which likely led to the reported polymer separation.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 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22910199
• Report Number: 2024168-2025-09180
• Device Sequence Number: 9055235
• Product Code: DQX
• UDI-Device Identifier: 08717648212123
• UDI-Public: (01)08717648212123(11)250421(17)270331(10)5042161
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K172073
• 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): 12/01/2025

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: 1013730
• Device Catalogue Number: 1013730
• Device Lot Number: 5042161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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
• Patient Sex: Unknown