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

Model Number	2078173
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - excessive force.
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, moderately calcified, right superior femoral artery that is 100% stenosed.After crossing the lesion, a non-abbott guide wire was exchanged for a 300cm ht (hi-torque) command guide wire.During advancement of the ht command guide wire, resistance was met with the microcatheter causing excessive force to be applied.The microcatheter was removed, soaked in saline, and reinserted into the patient when a kink was noted on the shaft of the ht command guide wire.During removal of the ht command guide wire, resistance with the microcatheter was noted, and the ht command guidewire was removed as a single unit.An unspecified command guidewire 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
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.The guide wire met resistance with the micro catheter and excessive force was applied.It should be stated in the instructions for use (ifu) states: do not: push, auger, withdraw, or torque a guide wire that meets excessive resistance.In this case, based on the reported information, the ifu violation was circumstantial due to the difficulties experience during advancement and removal.Based on the information received, a definitive cause for the reported difficulty could not be determined.Factors that may contribute to resistance advancing and removing the guide wire from the microcatheter include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, challenging anatomy which in this case moderately calcified and 100% stenosed femoral artery, user technique, and or damage to the catheter or guide wire.In this case, a kink was noted to 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 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: 22481110
• Report Number: 2024168-2025-07133
• Device Sequence Number: 7942627
• Product Code: DQX
• UDI-Device Identifier: 08717648176661
• UDI-Public: (01)08717648176661(11)250221(17)270131(10)5022171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 2078173
• Device Catalogue Number: 2078173
• Device Lot Number: 5022171
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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