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

Model Number VH-4000

Device Problem No Flow (2991)

Patient Problem Unspecified Infection (1930)

Event Date 07/28/2023

Event Type  Injury  

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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 evh stack (endoscopic tower - stryker camera, light, insufflation, monitors) would not insufflate air as a result we had to do a large leg incision standard size, without signs or sounds of gas escape.Incision length was extended out to approximately 10 inches distally to retrieve graft and the patient leg is oozing now likely infected.They made the call to open the leg distally from upper medial tibial incision.Opening of the lower leg to retrieve vein.A drain was not placed and there was no significant drainage seen.Tower, insufflator would not work.Stryker co2 settings 12 pressure, 5 flow.No leak noticed.Stryker onsite endoscope support staff helped troubleshoot endoscopic components and insufflator.They described the insufflation issues at the tower, "occlusion", and later was dealing with spotty visualization with the camera."they replaced co2 tubing and equipment." she was unaware of infection or delay in patient discharge from hospital.No procedural delay.

Manufacturer Narrative

(b)(4).A lot history record review was completed for lots 3000319484, 3000319625, and 3000319989 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.

Event Description

N/a.

• 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: 17592748
• MDR Text Key: 321621321
• Report Number: 2242352-2023-00694
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

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
• Device Operator: Health Professional
• Device Model Number: VH-4000
• Device Catalogue Number: VH-4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STRYKER TOWER CAMERA LIGHT MONITORS
• Patient Outcome(s): Required Intervention
• Patient Sex: Male