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

Model Number	1013731
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
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.
Event or Problem Description
It was reported that the procedure was to treat the superficial femoral artery (sfa) with no calcification or tortuosity.The command 18 guide wire was being torqued but then it was noted the torquing stopped.The wire was removed and it was found that the polymer coating on the tip had begun to peel.All of the coating was still on the wire and nothing remained in the patient, but it had begun to come off.Another command 18 guide wire was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported peeled/delaminated was confirmed.The reported difficult to advance could not be tested due to the device condition.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.It was reported that the guide wire encountered difficulty during advancement and was observed to have peeled polymer once removed from the anatomy.Factors that may contribute to difficulty during advancement 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.Additionally, factors that may contribute to polymer peeling include, but are not limited to, material properties, equipment setup, inadvertent handling damage, device placement technique, guiding catheter support, anatomical conditions/patient anatomical morphology, inner diameter of guide wire lumen of delivery/supporting device, outer diameter of the guide wire, condition of the guide wire, condition of the delivery/supporting device, and coagulation of blood or procedural contaminates.In this case, based on the information provided, it is unknown what may have contributed to the reported polymer peeling or difficulty during advancement.Additionally, during analysis of the returned wire, an irregular texture was noted on the core.Fourier transform infrared spectroscopy (ftir) was performed on the texture, and it was identified to possibly be a component of skin lotion.It is unlikely this texture originated from manufacturing.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 20258053
• Report Number: 2024168-2024-11083
• Device Sequence Number: 15324756
• Product Code: DQX
• UDI-Device Identifier: 08717648212130
• UDI-Public: (01)08717648212130(17)240930(10)2102561
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/19/2025

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: 09/30/2024
• Device Model Number: 1013731
• Device Catalogue Number: 1013731
• Device Lot Number: 2102561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 75 KG