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

Model Number	1013753
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was performed in the superficial femoral artery with moderate calcification and no tortuosity.The command 18 guide wire was advanced, but resistance was felt with the guiding catheter and the guide wire separated in two pieces.The guiding catheter with the separated guide wire were withdrawn from the patient anatomy without issue.A new guiding catheter and guide wire were used to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment due to the condition of the returned device.Additionally, polymer coating damages (stretched, torn, smashed, kinked) were noted.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 similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the guiding catheter and/or other devices resulted in the reported difficult to advance.Interaction/manipulation of the device resulted in the noted polymer coating damages (stretched, torn, smashed, kinked) and ultimately resulted in the reported/noted material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 15592344
• Report Number: 2024168-2022-10604
• Device Sequence Number: 16726498
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/13/2023

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: 05/31/2024
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 2061161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2022
• 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 Sex: Unknown