MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE STEEL CORE 18 GUIDE WIRE WITH MICROGLIDE® COATING

Model Number	1003282
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
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.The additional device is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion with heavily calcification and no tortuosity in the superficial femoral artery (sfa).The ht steelcore 18 guide wire was advanced but could not cross the lesion and during removal there was resistance with the anatomy and the tip became kinked and unraveled.A second guide wire was advanced, but had the same issue.Therefore, it was decided to use a non-abbott guide wire.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned guide wire and the reported core separation was confirmed.The reported failure to advance and remove were unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The investigation determined the reported failure to advance, difficulty to remove, tip break and kinks appear to be related to case circumstances of the procedure.In this case, based on the reported information, it is likely that during advancement and retraction against resistance, the coils likely stretched causing the appearance of kinks and a tip break.The noted bends on the core likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE STEEL CORE 18 GUIDE WIRE WITH MICROGLIDE® COATING
• 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: 14207598
• Report Number: 2024168-2022-04491
• Device Sequence Number: 1820735
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: 08717648013959
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K982876
• 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): 05/31/2022

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: 11/30/2023
• Device Model Number: 1003282
• Device Catalogue Number: 1003282
• Device Lot Number: 1120161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 77 KG