MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number VH-4000

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Chest Pain (1776); No Code Available (3191)

Event Date 07/09/2020

Event Type  malfunction  

Event Description

Elderly male with chest pain x 1 week and positive stress test.During the procedure for coronary artery bypass graft x 3, the bovie was not sealing branches.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10331679
• MDR Text Key: 200604445
• Report Number: 10331679
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: (01)00607567700406(17)220305(10)25150657
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 25150657
• 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: 07/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 145