MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC CORONARY ARTERY DISEASE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4001
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that during a saphenous endoscopic vessel harvesting procedure using vasoview hemopro 2 (w/vasoshield) (vh-4001).After the dissection process was completed, the harvester attempted to perform branch ligation.However, after attempting to harvest 2 small branches, the device would no longer activate when the toggle was pulled.In other words, the device would not ligate branches.The harvester did not feel that the device was overheated because it was only used to briefly ligate 2 small branches.Therefore, new cables and a new generator was used.Unfortunately, the device again failed to activate.The device was then deemed unsafe for use and was removed from the surgical field.A new kit was opened up.This kit worked as expected and the case was finished with no other issues.No injuries occurred due to the defect.Both generators used were set a 3.The only surgical delay was the time needed to open up a new kit and to switch out the cables and generators, which was about 3 to 5 minutes.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Updated section- b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 02/20/2025.An investigation was conducted on 03/18/2025.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The shaft of the device was observed to be bent in the center of the shaft.There were no visual defects observed on the intact heater wire.There were no visual defects observed on the clear intact silicone insulation on both the cold and hot jaws.The toggle was manipulated to open and close the jaws.The jaws would not open fully.An electrical evaluation was conducted.A pre-cautery test was performed per the direction for use (dfu) with a reference cable, adapter, and reference power supply vh-3010 at level 3.0.The device passed the pre-cautery test; it produced visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released.No excessive smoke and/or steam were observed during the testing.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after 10-second cooling period with no incident each time.An activation and transection capability test was performed over four (4) repetitions using "max life test method stm2048073.No further testing was conducted due to the condition of the shaft and the jaws not fully opening.Based on the returned condition of the device as well as the evaluation results, the reported failure " "electrical /electronic property problem" was not confirmed, however, the reported failure "material twisted/bent shaft" was confirmed.And the analyzed failure "mechanical problem- jaws " were observed.The lot # 3000442953 history record review was completed.There was one (1) ncmr , rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there s no relation between the batch manufacturing process and the reported failures or the analyzed failure.

• Brand Name: CORONARY ARTERY DISEASE
• 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: 21599567
• Report Number: 2242352-2025-0000267
• Device Sequence Number: 18197670
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451(10)3000442953(17)261215
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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-4001
• Device Catalogue Number: VH-4001
• Device Lot Number: 3000442953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2024
• 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: NO CONCOMITANT MEDICAL PRODUCTS WERE USED.
• Patient Sex: Unknown