MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 (W/VASOSHIELD); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4001
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trackwise # (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 or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2 (w/vasoshield) , more than halfway through harvesting radial artery endoscopically, the user lost their tunnel.The co2 was at the btt port at this time.They switched insufflation to distal and still could not get a tunnel.Patient was very muscular and they believed that may have been the problem.They considered switching out the tubing but they did not do that.Since they could not visualize the last few centimeters of the radial artery endoscopically, they ended up opening the arm to get the last segment.There was a delay.Patient is doing well.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise (b)(4).Updated section: b4, g3, g6, h2, h3, h6, h11 a lot of history record review was completed for lot 3000383564 lot shipped to the account prior to the event/aware date.There was 1 ncmr, 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 (W/VASOSHIELD)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 21229832
• Report Number: 2242352-2025-0000070
• Device Sequence Number: 20701982
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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-4001
• Device Catalogue Number: VH-4001
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 03/28/2025
• 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: NO.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown