MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT ELITE; WIRE, GUIDE, CATHETER

Model Number	1011880
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Interventional wire broke within coronary vessel.Fragment remains in body.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 20256638
• Report Number: 20256638
• Device Sequence Number: 20836481
• Product Code: DQX
• UDI-Device Identifier: 08717648144783
• UDI-Public: (01)08717648144783
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/27/2024
• Report Date (Section F): 08/27/2024

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
• Device Model Number: 1011880
• Device Catalogue Number: 1011880
• Device Lot Number: 4011971
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Date Report Sent to FDA: 08/27/2024