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

Model Number VASOVIEW HEMOPRO 2

Device Problems Electrical /Electronic Property Problem (1198); Smoking (1585); Environmental Particulates (2930)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Type  Injury  

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.Device discarded.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2.The device shut down and stopped activating for 1-2 minutes.After this time, the device worked for a few seconds, then stopped working again and smoke was coming out at the tip of the jaw.Case was completed successfully but a new kit needed to be used to complete the case.Patient experienced bleeding during and after the procedure.The bleeding was then stopped through tamponade pressure.

Event Description

The hospital reported, that during an endoscopic vein harvesting procedure using vasoview hemopro 2.The device shut down and stopped activating for 1-2 minutes.After this time, the device worked for a few seconds, then stopped working again and smoke was coming out at the tip of the jaw.Case was completed successfully, but a new kit needed to be used to complete the case.Patient experienced bleeding, during and after the procedure.The bleeding was then stopped through tamponade pressure.

Manufacturer Narrative

Updated sections: g4, g7, h2, h6, h10.Corrected sections h-6 - device code changed; patient codes changed.Trackwise # (b)(4).A lot history record review was completed for lots (b)(4) and (b)(4).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 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 07470
• MDR Report Key: 11109163
• MDR Text Key: 224807940
• Report Number: 2242352-2021-00011
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention