MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 (W/VASOSHIELD); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-4001
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a saphenous endoscopic vessel harvesting procedure, the harvester was using the vasoview hemopro 2 (w/vasoshield) (vh-4001).During the dissection process the harvester noticed that tunnel being created in the leg would not hold any co2 pressure.An attempt was made to adjust the co2 settings and there was still no co2 pressure being maintained.After pulling the endoscope out of the leg, the harvester notice that there was a tear in the rubber on the btt port.Therefore, the decision was made to open up an accessory kit (vh 2004) to get a new btt port.After this was done, the new btt port allowed for the co2 pressure to hold and the case was finished with no other complications.No injuries occurred due to the defect.The only surgical delay was the time needed to open an accessory kit which was about 3 minutes.
Additional Manufacturer Narrative
Tw (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.
Additional Manufacturer Narrative
(b)(4).Updated fields: b4, d8,g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11.The device was returned to the factory for evaluation on 01/28/2025.An investigation was conducted on 02/26/2025.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact btt.A 25 cc syringe, filled with air was attached to the inflation port line on the btt and squeezed the syringe to inject air.The btt was able to be inflated.A 25cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline with no issues.A 25cc 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 "inflation problem" was not confirmed.The lot # 3000440982 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: VASOVIEW HEMOPRO 2 (W/VASOSHIELD)
• 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: 21407165
• Report Number: 2242352-2025-0000174
• Device Sequence Number: 18221934
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451(10)3000440982(17)261207
• 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: Nurse
• 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: 3000440982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2024
• 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