MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 (W/VASOSHIELD); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW HEMOPRO 2 (W/VASOSHIELD)

Device Problems Improper Flow or Infusion (2954); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2020

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 2 (w/vasoshield).The physician assistant was using the hemopro 2 device (product number vh 4001) to harvest the radial artery.Throughout the entire case, the device was unable to maintain proper insufflation.The co2 insufflator machine and the co2 tubing were both changed out but there was no change in the pressure within the harvesting tunnel.Therefore, it was felt that the hemopro 2 kit was either not delivering co2 correctly or that it was unable to maintain the proper insufflation.The case was finished without injury to the patient.

Manufacturer Narrative

Corrected h-6 - device codes to "improper flow or infusion".Updated section: d-10, g-4, g-7, h-2, h-10.Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, using vasoview hemopro 2 (w/vasoshield).The physician assistant was using the hemopro 2 device (product number vh 4001) to harvest the radial artery.Throughout the entire case, the device was unable to maintain proper insufflation.The co2 insufflator machine and the co2 tubing were both changed out but there was no change in the pressure within the harvesting tunnel.Therefore, it was felt that the hemopro 2 kit was either not delivering co2 correctly or that it was unable to maintain the proper insufflation.The case was finished without injury to the patient.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, using vasoview hemopro 2 (w/vasoshield).The physician assistant was using the hemopro 2 device (product number vh 4001) to harvest the radial artery.Throughout the entire case, the device was unable to maintain proper insufflation.The co2 insufflator machine and the co2 tubing were both changed out but there was no change in the pressure within the harvesting tunnel.Therefore, it was felt that the hemopro 2 kit was either not delivering co2 correctly or that it was unable to maintain the proper insufflation.The case was finished without injury to the patient.

Manufacturer Narrative

Updated sections: d4,g4,g7,h2,h3,h6,h10.Internal complaint number: (b)(4).The device was returned to the factory on 06/17/2020.An investigation was conducted on 08/05/2020.A visual inspection was conducted.Signs of clinical use and heavy amounts of blood was observed on the cannula as well as on the intact c-ring.Sign of blood was also observed on the harvest tool handle and jaws.There were no visual defects observed on the harvesting device.The cannula was observed to be intact, no visual defects were observed.The insufflation tube and the water tube were observed to be intact with blood inside of the air tube.The c-ring appears to have been tainted with blood and tissue as it appears to be reddish in color.The c-ring has no visible defects.The device was evaluated for the presence or absence of air flow through the distal insufflation tube using a cannula with the help of calibrated uson.A reference endoscope was inserted into a reference vv7 cannula and an air supply was connected to the distal insufflation tubing luer fitting.Air did not passed through the insufflation port and was observed to not flow freely through the distal port.To verify this, a pouch was sealed over the distal tip of the cannula.Air was passed through the cannula and the pouch did not inflated.The test was then repeated for the reported cannula.The reference endoscope was inserted into the complaint device and evaluated for air flow.The device failed the air flow test, the co2 insufflation path on the complaint unit was closed and obstructed.Based upon the returned condition of the device and the results of the investigation, the reported failure "improper flow or infusion" was confirmed.

• Brand Name: VASOVIEW HEMOPRO 2 (W/VASOSHIELD)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10097553
• MDR Text Key: 192673379
• Report Number: 2242352-2020-00463
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: VASOVIEW HEMOPRO 2 (W/VASOSHIELD)
• Device Catalogue Number: VH-4001
• Device Lot Number: 25149564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• 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