MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM

Model Number	1012068-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported core break.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The other hi-torque versacore guidewire is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, 65% stenosed lesion in the superficial femoral artery (sfa).An ht versacore mod j 260cm guide wire (gw) was flushed in the hoop tray without issue.Upon advancing a non-abbott terumo sheath, resistance was met with the gw and the sheath, and the gw was removed.It was noted that there was a gap in the gw coils however the gw remained in one piece.A second ht versacore mod j 260cm gw was flushed in the hoop tray without issue, however upon advancing into the patient anatomy, the physician noticed the same issue with this gw, there was a gap in the coils but it remained in one piece.There was no reported resistance advancing the second gw.The gw was removed without issue.There was no adverse patient effect and no clinically significant delay in the procedure.A 3rd, non-abbott gw was used to complete the procedure.No additional information was provided.

• Brand Name: HI-TORQUE VERSACORE MODIFIED J GUIDE WIRE SYSTEM
• 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: 16218854
• Report Number: 2024168-2023-00743
• Device Sequence Number: 7492579
• Product Code: DQX
• UDI-Device Identifier: 08717648124235
• UDI-Public: 08717648124235
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083706
• 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
• Report Date (Section B): 01/20/2023

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: 08/31/2024
• Device Model Number: 1012068-09
• Device Catalogue Number: 1012068-09
• Device Lot Number: 2092661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO SHEATH
• Patient Sex: Male
• Patient Weight: 110 KG