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

Model Number	VASOVIEWHEMPRO (US) VH-3000
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10869167
• Report Number: 2242352-2020-01012
• Device Sequence Number: 2962970
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: 00607567700345
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K052274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR