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

Model Number	1013753
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.It was reported the wire was removed with force.It should be noted that ifu, ht guide wires instructions for use states: "carefully observe the instructions under "do not" and "do" below.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Do not: push, auger, withdraw or torque a guide wire that meets resistance.Torque a guide wire if the tip becomes entrapped within the vasculature.The ifu deviation likely did not cause the reported issue.Based on the information provided, a definitive cause for the reported issue could not be determined.In this case the wire may have been damaged during delivery, during delivery of the cardiomems; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional device mentioned in b5 will be filed under a separate medwatch report.
Event or Problem Description
It was reported the procedure was to implant a cardiomems sensor in a pulmonary artery.Two command 18 lt guide wires were used however during removal, resistance was met with the cardiomems delivery catheter.Force was applied in the attempts to remove the guide wire and once removed from the anatomy, it was noted the polymer coating on the guide wires were peeling [degloved] and twisted.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 24567478
• Report Number: 2024168-2026-00983
• Device Sequence Number: 15595711
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: (01)08717648211980(11)250217(17)270131(10)5021761
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 03/11/2026

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: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 5021761
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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: CARDIOMEMS DELIVERY CATHETER
• Patient Sex: Unknown