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

Model Number VASOVIEW 6 PRO

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

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 been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview 6 pro, issue with insufflation when using the btt.Co2 flow is restricted, when switch to distal insufflation no issues so it appears as though issue with btt.Pressure and flow settings were within ifu guidelines.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 6 pro, issue with insufflation when using the btt.Co2 flow is restricted, when switch to distal insufflation no issues so it appears as though issue with btt.Pressure and flow settings were within ifu guidelines.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory on 06/23/2020.An investigation was conducted on 08/05/2020.Signs of clinical use and no evidence of blood was observed on the btt.The gray silicone covering was observed to be puckered out, however there were no visual defects observed on the gray silicone on the btt.The btt was observed to be intact, no visual defects were observed.A mechanical investigation was conducted.The btt was able to inflate.No visual defects were observed on the silicone btt.A 5cc syringe, filled with saline was attached to the blue scope washer connector and squeezed the syringe to spray the saline.The saline went through the c-ring.No leaks or holes were observed during this process.The same process was repeated with the co2 line.A 5cc syringe, filled with saline was attached to the co2 line and squeezed the syringe to spray the saline.There was no backflow observed in the co2.No leaks or holes were observed during this entire process.Based on the condition of the device, the reported failure "no flow" is not confirmed.

• 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: 10252498
• MDR Text Key: 198525611
• Report Number: 2242352-2020-00595
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: VASOVIEW 6 PRO
• Device Catalogue Number: VH-2400
• Device Lot Number: 25150460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1