MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW VV6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-2400
Medical Device Problem Codes	Failure to Cut (2587); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during procedure using vasoview 6 pro, "the piece that grabs the vein wouldn't engage." they could not see it either.There was no delay, a new device was opened.No consequence from the event.No patient was harmed.
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
(b)(4).Updated field: b4, d9, g3, g6, h2, h3, h6 (medical device ¿ problem code, type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected field: d1.The device was returned to the factory for evaluation on 08/20/2025.An investigation was conducted on 08/20/2205.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact harvesting device handle.The c-ring was observed to be intact.The bipolar blades were not observed attached to the device.The detached bipolar blades were returned for evaluation.No electrical testing was conducted due to the detachment of the bipolar blades.Based on the returned condition of the device as well as the evaluation results, the reported failure "failure to cut" was confirmed.The lot # 3000461342 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.
Additional Manufacturer Narrative
Updated field: b4, g3, g6, h2, h11.Corrected field: h11.The device was returned to the factory for evaluation on (b)(6) 2025.An investigation was conducted on (b)(6) 2205.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact harvesting device handle.The c-ring was observed to be intact.The bipolar blades were not observed attached to the device.The detached bipolar blades were returned for evaluation.No electrical testing was conducted due to the detachment of the bipolar blades.Based on the returned condition of the device as well as the evaluation results, the reported failure "failure to cut" was confirmed.A manufacturing engineering evaluation was conducted.The complaint was confirmed.The bisector was inspected under magnification.It was observed that the bisector shaft had been severed into two pieces.See figures 1 through 4.Both pieces of the bisector shaft showed signs of damage around the leading edges indicating that it was physically cut.Both wires were cut and the metal wire that controls the blade was also severed.This essentially left the vv6 pro device without the ability to deliver power to the electrodes and actuate the blade.Based on the manufacturing engineering evaluation results, the reported failure "failure to cut" was confirmed.
Event or Problem Description
N/a.

• Brand Name: VASOVIEW VV6 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: 22806365
• Report Number: 2242352-2025-0000954
• Device Sequence Number: 8951349
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: (01)00607567700239(10)3000461342(17)270320
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2025

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 Model Number: VH-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000461342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 11/14/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 11/14/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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