MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7 XB BISECTOR (US); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW 7 XB BISECTOR (US)

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

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 7 xb bisector.Customer experienced high co2 pressure alarm.After troubleshooting customer has indicated the issue is with the btt.They have exchanged tower, co2 tubing and alarm continues.When they remove the trocar from the leg and reconnect it, the alarm continues to occur.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected section: h-3 - if other provide code -explain, d- 4 - exp.Date corrected d-4 to reflect the correct updated information 11/08/2021 corrected h-3 to reflect "device discarded" updated sections: g-4, g-7, h-2, h-6, h-10 internal complaint number: tw #(b)(4).H3 other text : device discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector.Customer experienced high co2 pressure alarm.After troubleshooting customer has indicated the issue is with the btt.They have exchanged tower, co2 tubing and alarm continues.When they remove the trocar from the leg and reconnect it, the alarm continues to occur.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASOVIEW 7 XB BISECTOR (US)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9736162
• MDR Text Key: 185952781
• Report Number: 2242352-2020-00162
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K041981
• 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: 02/17/2020

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: 11/08/2021
• Device Model Number: VASOVIEW 7 XB BISECTOR (US)
• Device Catalogue Number: VH-3200
• Device Lot Number: 25148881
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1