MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW HEMOPRO 2

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(6).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

Related to 701213 the hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 tunnel would not insufflate.Extended anesthesia time, prolonged or time.Opened a new kit to continue case.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 tunnel would not insufflate.They were having trouble getting a gas pressure reading and were unsure of the cause of gas loss or failure to inflate.The setting on co2 were 3 flow and 10 pressure.Then changed to 5 flow and 12 pressure.No marked change was noticed in the tunnel.The tunnel seemed to be breathing (expanding and retracting over and over again).They were observing a constant flow of 3 and then 5.Pressure would go up and down over and over, never hitting target pressure.Several attempts were made both proximal and distal to connect and reconnect the gas port.End user was unable to get either port to hold the gas.At one point they added an bifurcated perfusion tubing that allowed the gas to flow to both ports at the same time.There was delay due to trouble shooting the co2 tunnel issue and extended anesthesia time, prolonged or time.Opened a new kit to continue case.Pa followed up and there were no further reported patient effects.

Manufacturer Narrative

Trackwise#: (b)(4).

Manufacturer Narrative

Trackwise#: (b)(4), the device was returned to the factory for evaluation on 11/05/2022.An investigation was conducted on 11/16/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The heater wire on the harvesting device was observed to be slightly flexed away from the hot jaw due to normal clinical use.There were no visual defects observed on the clear silicone insulation on both the cold and hot jaws.There were no visual defects observed on the cannula or the intact c-ring.The btt was observed to be intact, with no visual defects observed.A mechanical evaluation was conducted.The btt was able to be inflated.No visual defects were observed on the silicone btt.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.The cannula was observed to be intact, no visual defects were observed.The insufflation tube and the water tube were observed to be intact.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 (id 14332 due: 01/31/2023).A reference endoscope was inserted into a reference vv7 cannula and an air supply was connected to the distal insufflation tubing luer fitting.Air was passed through the insufflation port and was observed to 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 was inflated.The air supply was stopped and the pouch stayed inflated.When gentle pressure was applied to the inflated pouch, the pouch deflated slightly, the air was turned back on and the pouch re-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 passed the air flow test, the co2 insufflation path on the complaint unit was open and unobstructed.The values displayed were within specified acceptable range which is 2195 sccm.Based on the condition of the device, the reported failures "improper flow or infusion" was not confirmed.The lot # 25159631 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 15686179
• MDR Text Key: 305605197
• Report Number: 2242352-2022-00880
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25159631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 85 KG