MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE

Model Number	1013753
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was performed to treat a lesion in the left anterior tibial artery with moderate calcification and mild tortuosity.A command 18 guide wire was advanced in the vessel without resistance, followed by an armada 18 balloon catheter.When the command guide wire was being removed there was resistance with the balloon catheter.Both devices had to be removed as one unit.Once outside the patient anatomy, it was noted that coating of the guide wire had peeled off the tip of the guide wire.The armada 18 balloon catheter was flushed, and the separated coating was flushed completely.There was no coating in the patient's anatomy present.A steelcore guide wire was used with the same armada 18 balloon catheter without issue.There was no issue with the armada 18 balloon catheter.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported peeling was confirmed.The reported difficulty to remove from the balloon catheter was unable to be confirmed due to the returned condition of the guide wire.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaint reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to remove and polymer peeling appear to be related to case circumstances of the procedure.In this case, based on the reported information, it is likely that during use, the polymer became damaged against the anatomy and/or other devices used resulted in the reported difficulty to remove from the balloon catheter.Manipulation against resistance ultimately resulted in the polymer tears and separation causing the appearance of peeling.The noted bends on the guide wire likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 13458086
• Report Number: 2024168-2022-01210
• Device Sequence Number: 4675444
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152404
• 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): 03/15/2022

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: 11/30/2022
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 0121561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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: 6FR SHEATH.; ARMADA 18 BALLOON CATHETER.
• Patient Sex: Unknown