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

Model Number VASOVIEW HEMOPRO 2

Device Problem Inflation Problem (1310)

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

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2.The pa doing the case had a hard time keeping the tunnel inflated.The case was going fine and the tunnel was inflating as he was doing the dissection with the scope.When they tried to switch over to the cutting tool/cannula, the tunnel wouldn't inflate.They tried several thing to troubleshoot.Everything they tried failed to keep co2 in the tunnel and inflating the tunnel.They went back to inserting the scope, and the tunnel did stay inflated.When using the scope is the only time the tunnel would stay inflated.Nothing else worked.The case was completed by opening a terumo device.No patient harm or incident.

Manufacturer Narrative

Trackwise (b)(4).Analysis of production for ship history conducted: (3331/213/67) a lot history record review was completed for lots 25159401, 25159402, and 25159584 the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the reported lot numbers.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2019 through sept 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.

• 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: 12587238
• MDR Text Key: 278625179
• Report Number: 2242352-2021-00813
• 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
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1