MAUDE Adverse Event Report: MICROVENTION, INC. / ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	1001782J-HC
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Abbott hi-torque balance middleweight guide wire used during cerebral thrombectomy was damaged and unusable during case.Coating peeled off wire prior to its use.Impaired and packaging saved for manufacturer inspection.Fda safety report id # (b)(4).

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MICROVENTION, INC. / ABBOTT VASCULAR
• MDR Report Key: 13026184
• Report Number: MW5106146
• Device Sequence Number: 14810867
• Product Code: DQX
• UDI-Device Identifier: 08717648026010
• UDI-Public: (01)08717648026010
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 10/31/2022
• Device Model Number: 1001782J-HC
• Device Catalogue Number: 1001782J-HC
• Device Lot Number: 0111272
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown