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

Model Number	1013731
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the distal superficial femoral artery, popliteal, and posterior tibial artery.Following pre-dilation of the vessel with an unknown balloon, three 10cm ht command 18 guidewires (gw) were attempted to be advanced and were noted to have difficulty when being inserted into the 5 french micro sheath, and the coating became bunched at the tip.Therefore, a new command wire was used and advanced through the same sheath successfully and the procedure was completed.There was no adverse patient effect and no clinically significant delay in the procedure.One device was received and return analysis revealed that the polymer coating was separated, torn and folded over itself.Additional information was received that the reported coating becoming bunched at the tip meant that the polymer coating was separated and folded over itself with tear being noted.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.The additional devices referenced in b5 are filed under separate medwatch numbers.
Additional Manufacturer Narrative
Visual inspection and dimensional analysis were performed on the returned device.The reported polymer damages were confirmed.The reported difficulty to advance was not confirmed as it cannot be replicated in a testing environment and due device condition.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 for the reported issue could not be determined.Factors that may contribute to difficulty advancing the guide wire into a sheath include, but are not limited to, inner diameter of the sheath, device support, buildup of procedural contaminants, challenging anatomy, user technique, and/or damage to the sheath or guide wire which likely led to the reported damages to the polymer coating.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.H6 correction: medical device problem code 1454 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23213883
• Report Number: 2024168-2025-10888
• Device Sequence Number: 9130944
• Product Code: DQX
• UDI-Device Identifier: 08717648212130
• UDI-Public: (01)08717648212130(11)250714(17)270630(10)5071461
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 10/31/2025

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: 1013731
• Device Catalogue Number: 1013731
• Device Lot Number: 5071461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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: SHEATH: 5 FRENCH MICRO PUNCTURE
• Patient Sex: Unknown