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

Model Number	VH-2400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
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 while testing the device vasoview 6 pro, before going into the patient, the entire "c" ring assembly became detached from the harvesting cannula.They attempted to re-insert the "c" ring assembly back into the harvesting cannula with no success.A new device was opened to complete the case.There were no known patient harm/effects.No procedural delay.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw#(b)(4).The device was returned to the factory for evaluation on 12/04/2024.An investigation was conducted on 01/22/2025.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact bipolar blades or the intact cutter blade.The c-ring was observed to be intact, however, the c-ring body was observed to be detached from the device.There were no other visual defects observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "break" was confirmed.A manufacturing engineering evaluation was conducted.The complaint was confirmed for the failure mode "break".The device showed signs of heavy clinical use.Upon further observation, it was noted that the c-ring wire (cv000000338) had completely detached from the c-ring molded nozzle (rm2047671 ).There was no visible damage to the c-ring molded nozzle (rm2047671).There was no visible damage to the c-ring wire (cv000000338).Based on the returned condition of the device as well as the manufacturing engineer evaluation results, the reported failure "break" was confirmed.The lot # 3000397982 history record review was completed.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 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: 20931815
• Report Number: 2242352-2024-0001363
• Device Sequence Number: 5107973
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: (01)00607567700239(10)3000397982(17)260603
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 06/03/2026
• Device Model Number: VH-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000397982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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: OPCAB PROCEDURE.
• Patient Sex: Unknown