MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-2400
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro co2 port was not working properly.Gas supply (co2) connection seems closed.As a result, no co2 came through the plug.After much searching where the problem was, it turned out to be the solution after taking a new plug (from a loosely packed accessory pack).No harm to the patient.There was a delay of about 10 minutes.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro co2 port was not working properly.Gas supply (co2) connection seems closed.As a result, no co2 came through the plug.After much searching where the problem was, it turned out to be the solution after taking a new plug (from a loosely packed accessory pack).No harm to the patient.There was a delay of about 10 minutes.A replacement device was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation on 01/17/2025.An investigation was conducted on 01/27/2025.A visual inspection was conducted.Sings of clinical use and evidence of blood was observed.There were no visual defects observed on the intact btt.A 5cc syringe filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.Based on the returned condition of the device as well as the evaluation results, the reported failure "improper flow or infusion" was not confirmed.The lot # 3000405184 history record review was completed.There was a 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 6 PRO
• 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: 20871324
• Report Number: 2242352-2024-0001334
• Device Sequence Number: 8574536
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: (01)00607567700239(10)3000416465(17)260830
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K091733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2026
• Device Model Number: VH-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000416465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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.
• Patient Sex: Unknown