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

Model Number VASOVIEWHEMPRO (US) VH-3000

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

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.Device discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro.The harvesters who are using vh-3000 were complaining of issues with poor insufflation from the btt port during dissection.When switching to distal insufflation by hooking the co2 to the cannula, the issue stopped.They have opened a number of accessory trays to use the btt ports out of those trays rather than the port included in the vh-3000 kit.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro.The harvesters who are using vh-3000 were complaining of issues with poor insufflation from the btt port during dissection.When switching to distal insufflation by hooking the co2 to the cannula, the issue stopped.They have opened a number of accessory trays to use the btt ports out of those trays rather than the port included in the vh-3000 kit.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: g4,g7,h2,h6,h10.Trackwise # (b)(6).A lot history record review was completed for lots 25148770,25148705, and 25148496 the last 3 lots shipped to the account prior to the event date.There were no ncmr's recorded in the lot history.

• Brand Name: VASOVIEWHEMPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9566440
• MDR Text Key: 188403177
• Report Number: 2242352-2020-00034
• Device Sequence Number: 1
• Product Code: GEI
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEWHEMPRO (US) VH-3000
• Device Catalogue Number: VH-3000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1