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

Model Number	VH-2004
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 equipment showed that ¿insufflation was active,¿ but the harvester was struggling with the view of the vein on the monitor.Another harvester was paged upon this discovery and then it began working on its own before they made it to the room.Approximately an hour later, the equipment was alarming that there was an ¿occlusion.¿ harvester paged the other harvester again and obtained new insufflation tubing and vasoview accessory kit, in the event that it was a part of the issue.Harvester was unable to troubleshoot with the new supplies and the paged harvester was unable to troubleshoot the equipment.A new pneumoclear co2 conditioning insufflator was brought to the room and set up by the second harvester.The new equipment worked; however, at this point the harvester had to ¿go open¿ in order to retrieve the vein from the patient¿s leg.This caused four additional incisions in the patient¿s leg and a delay in the surgery.
Additional Manufacturer Narrative
Tw 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.
Additional Manufacturer Narrative
Trackwise #: (b)(4).A lot history record review was completed for lots 3000358119, 3000330649, and 3000315024 the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last 3 lots shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.
Event or Problem Description
N/a.

• Brand Name: VASOVIEW EVH ACCSESSORY PACK
• Common Device Name: 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: 19037575
• Report Number: 2242352-2024-00331
• Device Sequence Number: 12803732
• Product Code: GEI
• UDI-Device Identifier: 00607567700376
• UDI-Public: 00607567700376
• Combination Product (Y/N): N
• Initial Reporter State: WV
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VH-2004
• Device Catalogue Number: VH-2004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown