MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW 6 PRO

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).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 6 pro, 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.B5 correction: event description; h3 correction: device not returned, changed to device discarded; h6 correction: device not returned, changed to device discarded.Internal complaint number: (b)(4).A lot history record review was completed for lots 25148040, 25148215 and 25148596 the last 3 lots shipped to the account prior to the event date.There were no ncmr's recorded in the lot history.H3 other text : the device was discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview 6 pro.They had issues in several cases with c02 levels, after troubleshooting it appears as though it might be issue with the btt.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASOVIEW 6 PRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9809159
• MDR Text Key: 185739464
• Report Number: 2242352-2020-00213
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K091733
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW 6 PRO
• Device Catalogue Number: VH-2400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1