MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

Model Number	1009661
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to abbott vascular 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 identified no other similar incidents and/or complaints 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 tip separation appear to be related to operational circumstances of the procedure.In this case, it is likely that during advancement the guide wire tip became damaged resulting in the difficulty to remove during retraction.Manipulation against resistance ultimately resulted in the reported tip separation.Additionally, the treatment appears to be related to the operational context of the procedure as the separated portion of the guide wire was removed using a snare device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat the superficial femoral artery.A 300 cm hi-torque balance middleweight guidewire was advanced to the target lesion without issue.Then upon removal, resistance met with the anatomy, and the distal tip of the guidewire became detached into the leg.The proximal end of the guidewire was removed, and an unspecified catheter was advanced and the separated tip was removed with a snare.The procedure continued and the target lesion was successfully completed with an unspecified guidewire.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12624390
• Report Number: 2024168-2021-09187
• Device Sequence Number: 3292197
• Product Code: DQX
• UDI-Device Identifier: 08717648014345
• UDI-Public: 08717648014345
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 1009661
• Device Catalogue Number: 1009661
• Device Lot Number: 1052171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention