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

Model Number	1012068-05
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the hi-torque (ht) versacore guide wire, the tip separated.Another same size ht verscore guide wire was used to complete the procedure.There was no device use or patient involvement.There was 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 tip material separation was unable to be confirmed; however, there was noted stretched tip coils.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 from this lot.As there was no reported 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 preparation for use inadvertent mishandling resulted in the reported tip material separation/noted stretched tip coils.The noted multiple bends throughout the entire length of the guide wire likely occurred due to handling or during packaging for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 15422483
• Report Number: 2024168-2022-09733
• Device Sequence Number: 6581652
• Product Code: DQX
• UDI-Device Identifier: 08717648124198
• UDI-Public: 08717648124198
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 09/21/2022

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: 04/30/2024
• Device Model Number: 1012068-05
• Device Catalogue Number: 1012068-05
• Device Lot Number: 2051761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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