MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO (US) VH-3000

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise 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.

Event Description

The hospital reported that during anendoscopic vein harvesting procedure using vasoview hemopro vh-3000, the co2 would not flow into the tunnel.They were able to get pressure but could not get flow when the gas was connected to the port.They opened up a 3 way stop cock and still could not get flow.The setting on the insufflator were at 12 mm/hg and 5 l/min and they were getting adequate co2 out of the tubing when putting up to their faces, but once connected to the btt port the flow would not flow into the leg.At that point they opened a new device and were able to get flow and finish the harvest.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro vh-3000, the co2 would not flow into the tunnel.They were able to get pressure but could not get flow when the gas was connected to the port.They opened up a 3 way stop cock and still could not get flow.The setting on the insufflator were at 12 mm/hg and 5 l/min and they were getting adequate co2 out of the tubing when putting up to their faces, but once connected to the btt port the flow would not flow into the leg.At that point they opened a new device and were able to get flow and finish the harvest.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The lot # 25150502 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: VASOVIEWHEMPRO (US) VH-3000
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10869167
• MDR Text Key: 217162575
• Report Number: 2242352-2020-01012
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: 00607567700345
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• 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: 11/18/2020

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: 02/26/2021
• Device Model Number: VASOVIEWHEMPRO (US) VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25150502
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR