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

Model Number	VH-4001
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been returned to the factory and will be evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that during harvesting of the saphenous vein there was used the vasoview hemopro 2 (w/vasoshield).After branch dissection was completed, branch ligation was attempted.However, when the co2 line was attached to the distal insufflation site, the co2 machine read "occluded".The line was removed and reattached and the same issue occurred.Due to this defect, the device was removed from the surgical field and new kit was opened.The new device was attached to the co2 line and there was no issue with the flow of co2.The remainder of the case was finished with no other complications.No injuries occurred due to the defect.The only surgical delay was the time need to open a new kit which was less than 3 minutes.
Additional Manufacturer Narrative
Tw (b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 03/02/2026.An investigation was conducted on 03/04/2026.A visual inspection was conducted.Only the cannula was returned for evaluation.There were no visual defects observed on the intact cannula or intact c-ring.A syringe was filled with 30cc of air.The syringe was then connected to the luer lock valve attached to the insufflation tubing.The plunger on the syringe was depressed and all 30cc of air was delivered with unimpeded flow of air through the insufflation tubing.The complaint cannula device was submerged in water.A syringe was filled with 30cc of air.The syringe was then connected to the luer lock valve attached to the insufflation tubing.The plunger on the syringe was depressed and all 30cc of air was delivered with unimpeded flow of air through the insufflation tubing as evidenced by the visible air bubbles.Based on the returned condition of the devices and the evaluation results, the reported failure "infusion or flow problem" was not confirmed.The lot # 3000530455 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: 24566159
• Report Number: 2242352-2026-0000168
• Device Sequence Number: 9561681
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451(10)3000530455(17)280129
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 3000530455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2026
• 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.
• Patient Sex: Unknown