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

Model Number	1013731
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the posterior tibial artery (pta).The ht command guidewire (gw) was advanced into the anatomy however the coating on the gw was noted to be bunched and torn.The gw was replaced with a non-abbott gw and the procedure was completed.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.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 bunched polymer and torn polymer were 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 determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that after advancing the guide wire into the anatomy, the polymer was observed to be bunched and torn.Analysis of the returned wire noted holes in the polymer consistent with repeated interaction with an accessory device or the anatomy.Additionally, the polymer was bunched distally, indicating the wire was pulled against resistance.In this case, it is likely that the wire was manipulated against resistance, resulting in the polymer bunching and tears.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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20620157
• Report Number: 2024168-2024-12981
• Device Sequence Number: 7534739
• Product Code: DQX
• UDI-Device Identifier: 08717648212130
• UDI-Public: (01)08717648212130(17)260430(10)4050861
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 02/06/2025

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: 1013731
• Device Catalogue Number: 1013731
• Device Lot Number: 4050861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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 Age: 66 YR
• Patient Sex: Male