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

Model Number	VH-2400
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise # (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 the cautery wouldn't work on device.Traded out cords and troubleshooted.New device functioned.Slight delay in case due to troubleshooting and replacement.There was no patient harm.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,b5,d9,g3,g6,h2,h3,h6,h11.Corrected section: d10,b7.The device was returned to the factory for evaluation on 01/21/2025.An investigation was conducted on 02/17/2025.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact c-ring or the intact bipolar blades.The blue toggle was manipulated to retract and extend the cutter blade.There were no visual defects observed on the intact cutter blade.An electrical evaluation was conducted.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use (cv000001597).The device passed the pre-cautery test with a reference generator (recommended setting of 18) and reference bipolar cord.The bipolar cord connection was manipulated during activation.The device did produce steam and the saline did ¿boil¿ on the test gauze each time.To test the ability of the device to cut, a cautery test was performed on artificial vessel.The device was able to cut reference vessels cleanly.Based on the returned condition of the device as well as the evaluation results, the reported failure "failure to cut" was not confirmed.A lot history record review was completed for lots 3000426407 and 3000427412 the last 2 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last 2 lots shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The lot # 3000419771 history record review was completed.There was one (01) ncmr identified.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
Event or Problem Description
The hospital reported during the procedure, the vasoview 6 pro cautery wouldn't work on device.Traded out cords and troubleshooted.New device functioned.Slight delay in case due to troubleshooting and replacement.There was no patient harm.

• 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: 21185111
• Report Number: 2242352-2025-0000067
• Device Sequence Number: 19905151
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: (01)00607567700239
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/04/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CORDS
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 98 KG