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

Model Number VASOVIEWHEMPRO (US) VH-3000

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

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 hemopro, they were not getting any co2 insufflation to inflate the tunnel.The end user tried using the "distal insufflation" port and still had no insufflation.Co2 was flowing to the end point.They tried to depress the blue valve and could not so they tried removing the blue valve.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: d10, g4, g7, h2, h3, h6, h10 trackwise # 301532 the device was returned to the factory on (b)(6)2020.An investigation was conducted on (b)(6)2020.A visual inspection was conducted.The c-ring & cannula handle appeared intact.Signs of clinical use and evidence of blood was observed.Blood was observed on the tubes as well as the btt.The end of the insufflation tube was observed to be damaged.It appears as if tape residue was observed on the end of the insufflation tube.The distal end of the insufflation tube was observed to be taped at the end.We are unable to determine when the tape was put on the tube.However, based on the returned condition of the device, we are unable to test the device for the reported failure due to the tape.However, the reported failure ¿no flow¿ was confirmed as well as the analyzed failure, "break- tube damaged".The dhr.Shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro, they were not getting any co2 insufflation to inflate the tunnel.The end user tried using the "distal insufflation" port and still had no insufflation.Co2 was flowing to the end point.They tried to depress the blue valve and could not so they tried removing the blue valve.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASOVIEW HEMPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9914079
• MDR Text Key: 186733308
• Report Number: 2242352-2020-00326
• 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: 05/18/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2021
• Device Model Number: VASOVIEWHEMPRO (US) VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25149479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 05/18/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1