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

Model Number	2078175
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the command 14 guide wire with a non-abbott microcatheter, there was resistance between the devices and they had to be removed together.Outside the anatomy it was noted that the command guide wire became 'stripped'.There were no reported adverse patient effects and there was a delay in the procedure, but no harm was reported.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.B3: date of event estimated.D4: a partial udi was provided as the lot number is not known.
Event or Problem Description
Subsequent to the initially filed report it was reported that a clinically significant delay occurred.The coating on the wire was bunched up rather than stripped.The patient had worsening pain and a digital dry necrosis wound on the toe which was not healing properly.There was thrombosis noted and the patient required amputation in another procedure to treat the thrombosis.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.B1: adverse event/product problem updated from "product problem" to "adverse event, product problem".B2: outcomes attributed to ae updated from "na" to "disability or permanent damage; hospitalization-initial or prolonged; required intervention".B3: date of event corrected from 7/1/2025 to 7/18/2025.H1: type of reportable event updated from "malfunction" to "serious injury".D9: device available for evaluation updated from "ni" to "no".H6: health effect - clinical code 4582 was removed.H6: health effect - impact code 2199 was removed.
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.The subsequent treatment appears to be related to circumstances of the procedure.Factors that may contribute to difficulty advancing and removing a catheter over the guide wire 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, user technique, and/or damage to the catheter or guide wire which likely led to the reported peeling/ stripped of the guide wire.The patient effects of thrombosis and infection are known risks of the procedure.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.D4: primary udi number correction: (b)(4).D4: corrected lot number from unknown to 5041472.D4: expiration date 3/31/2027 was added.H4: device mfr date 4/14/2025 was added.

• 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: 22773487
• Report Number: 2024168-2025-08304
• Device Sequence Number: 9585319
• Product Code: DQX
• UDI-Device Identifier: 08717648176685
• UDI-Public: (01)08717648176685(11)250414(17)270331(10)5041472
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: 2078175
• Device Catalogue Number: 2078175
• Device Lot Number: 5041472
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 01/05/2026
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/01/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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: TERUMO NAVICROSS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 75 YR
• Patient Sex: Male