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

Model Number VH-4000

Device Problem Environmental Particulates (2930)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/27/2024

Event Type  Injury  

Event Description

Related to tw (b)(4).The hospital reported that during an endoscopic vessel harvesting procedure, vasoview hemopro 2 generated a large amount of white smoke - enough so that the harvester was not able to visualize much of the cutting.The tissue was connective and frank blood.The jaws were clear of char as the harvester kept clearing them throughout the case.The evacuation channel was used with limited success as well as switching between proximal and distal insufflation.There was bleeding that began during dissection.There was also a fair bit of blood pooled in the bottom of the tunnel in the thigh during sealing and cutting.Blood loss was not measured.No additional transfusions were required.A new device was opened to complete the procedure and there was immediate heavy smoking with the second device as well.The procedure was completed with the second device.There was a procedural delay.There was no patient injury.

Manufacturer Narrative

Tw id# (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 19183779
• MDR Text Key: 341065984
• Report Number: 2242352-2024-00423
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Device Lot Number: 3000374163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 87 KG