MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VV 6 ACCESSORY PACK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-2004
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id# (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 during an endoscopic vessel harvesting procedure, the vv6 (vh-2004) co2 would not flow through the btt.An occlusion error occurred on the insufflator.Harvester attempted to connect the co2 to the btt a few times to ensure a proper connection but co2 wouldn't flow through the btt.An occlusion error appeared on the insufflator.There was no procedural delay.No harm or effects were caused to the patient.
Additional Manufacturer Narrative
Tw# (b)(4).The device was returned to the factory for evaluation on 12/26/2024.An investigation was conducted on 01/27/2025.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the intact btt.The device was returned with a cut tube that connects to the btt.There were no visual defects observed on the intact btt.The btt was able to be inflated.No visual defects were observed on the silicone 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 # 3000428128 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.
Event or Problem Description
N/a.

• Brand Name: VV 6 ACCESSORY PACK
• 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: 21118527
• Report Number: 2242352-2025-0000027
• Device Sequence Number: 18326243
• Product Code: GEI
• UDI-Device Identifier: 00607567700376
• UDI-Public: (01)00607567700376(10)3000428128(17)261015
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K041981
• 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
• Report Date (Section B): 04/15/2025

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-2004
• Device Catalogue Number: VH-2004
• Device Lot Number: 3000428128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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 PRODUCTS USED
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 80 KG