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

Model Number	2078172
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed, moderately calcified lesion in the superficial femoral artery with the 190cm ht command 14 guide wire (gw).The tip felt stiffer than a usual; however, the gw was advanced into the patient anatomy.After the lesion was crossed using a non-abbott guiding catheter, the command gw was exchanged for a non-abbott 300cm gw due to needing a longer size.After withdrawal, the tip load was again inspected and noted to feel significantly stiffer than usual.An unspecified balloon dilatation catheter was used to complete the procedure.There was no adverse patient effects and no clinically significant delay.Returned device analysis identified that there was a separation of the distal core, polymer coating, coils, and distal solder tip.Additional information received from the site indicated that no portion of the separated device remained in the patient anatomy; however, it was unknown when the separation occurred.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 was performed on the returned device.The reported material too rigid or stiff was unable to be confirmed.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported material too rigid or stiff.It was reported that the wire felt stiffer than usual.Factors that may contribute to the wire feeling stiff or rigid include, but are not limited to, material properties, coil outer diameter, flat dimensional grind, or user technique.Analysis of the wire indicated no manufacturing anomalies.It is unknown what contributed to the stiff feeling.Additionally, analysis of the wire noted a separated at the distal tip.The separation face was angles, indicating the wire was subject to force at a kink or bend.It was confirmed that the separation was not noted during use, likely occurring due to post procedural handling or shipping.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 21063472
• Report Number: 2024168-2025-00080
• Device Sequence Number: 11582921
• Product Code: DQX
• UDI-Device Identifier: 08717648176654
• UDI-Public: (01)08717648176654(17)260430(10)4051471
• 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): 02/12/2025

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 Expiration Date: 04/30/2026
• Device Model Number: 2078172
• Device Catalogue Number: 2078172
• Device Lot Number: 4051471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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