MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS WITH RADIAL INDICATION; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number VSP550EX

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  malfunction  

Event Description

Elderly male with history of poor circulation of right lower extremity.Procedure: right iliofemoral endarterectomy with iliac stenting and right femoral to posterior tibial bypass.While cauterizing, the tip of the device broke off.It was able to be removed from the patient.No known harm to patient at this time.

• Brand Name: VIRTUOSAPH PLUS WITH RADIAL INDICATION
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 19212336
• MDR Text Key: 341375434
• Report Number: 19212336
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769(17)260831(10)39K
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VSP550EX
• Device Lot Number: 39K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male