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

Model Number VASOVIEWHEMPRO VH-3500

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh-3500.No co2 flow getting into the tunnel through both the proximal and distal co2 port.Co2 was flowing normal through from the insufflator but once connected to the ports, no flow.The btt port was first changed and had same issues then the a new vh-3500 was opened and the problem continued.The case continued with no co2 flow but as the pa worked the way to the end of the tunnel and started to come back, the co2 started working at about 50%.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh-3500.No co2 flow getting into the tunnel through both the proximal and distal co2 port.Co2 was flowing normal through from the insufflator but once connected to the ports, no flow.The btt port was first changed and had same issues then the a new vh-3500 was opened and the problem continued.The case continued with no co2 flow but as the pa worked the way to the end of the tunnel and started to come back, the co2 started working at about 50%.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).

• Brand Name: VASOVIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9996131
• MDR Text Key: 190828772
• Report Number: 2242352-2020-00395
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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 Operator: Health Professional
• Device Expiration Date: 01/19/2021
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 25149798
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1