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

Model Number	2078173
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the posterior tibial artery.The creation of a fistula between the posterior tibial artery and posterior tibial vein through the use of a limflow system was attempted; however, due to the calcium the guidewire for an orbital atherectomy could not cross the lesion.Therefore, a 300cm ht command 14 guidewire was advanced into the anatomy however was noted to separate in the occluded lesion.The separated portion was left in the anatomy and there were no adverse patient sequela nor clinical delay.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
The device was not returned for analysis.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 difficulties or patient effect.It was reported that the guide wire encountered difficulty during advancement and subsequently separated due to device interaction.Factors that may contribute to difficulty during advancement of the guide wire include, but are not limited to, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, challenging anatomy, interaction with accessory devices, and/or damage to the guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported difficulty during advancement or removal.Additionally, it was reported that the material separation was due to interaction with an accessory device.The separated portion of the tip remains within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the posterior tibial artery.The creation of a fistula between the posterior tibial artery and posterior tibial vein through the use of a limflow system was attempted; however due to the calcium the guidewire for an orbital atherectomy could not cross the lesion.Therefore a 300cm ht command 14 guidewire was advanced into the anatomy however was noted to separate in the occluded lesion.The separated portion was left in the anatomy and there were no adverse patient sequela nor clinical delay.Subsequent to the initially filed report, additional information was provided: the tip of the 300cm ht command 14 guidewire was noted to separate in the occluded lesion due to device interaction with the orbital atherectomy device.The separated portion was left in the occluded vessel where snaring was not possible and it would cause no harm to the patient.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 # 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: 21123478
• Report Number: 2024168-2025-00415
• Device Sequence Number: 15312490
• Product Code: DQX
• UDI-Device Identifier: 08717648176661
• UDI-Public: (01)08717648176661(17)260630(10)4071971
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: 2078173
• Device Catalogue Number: 2078173
• Device Lot Number: 4071971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown