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

Model Number	VH-4001
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that the c-ring from the vasoview hemopro 2 (with vasoshield) was bent or broken.The opening within the c-ring was significantly wider than normal.The entire saphenous vein harvest was completed, and the harvester subsequently removed the harvesting cannula.No injury occurred as a result of the defect, and the case was completed without any complications.No parts of the c-ring broke off.
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.
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 (b)(6) 2025.A photograph was provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of slight blood was observed on the c-ring.The opening within the c-ring was significantly wider than normal.No other visual defects were observed in the photograph.An investigation was conducted on (b)(6) 025.A visual inspection was conducted.Signs of clinical use and evidence of slight blood was observed on the c-ring.There were no visual defects observed on the intact cannula handle.The c-ring was observed to be significantly wider than normal.The scope wash tubing and the c-ring remained attached to the cannula.Based on the returned condition of the device as well the evaluation results, the reported failure "material twisted/bent- c-ring" was confirmed.A manufacturing engineering evaluation was conducted; a visual inspection was conducted.Signs of clinical use and evidence of slight blood was observed on the c-ring.There were no visual defects observed on the intact cannula handle.The c-ring was observed to be misshapen.The c-ring was inspected under magnification and it was observed that it was misshapen when compared to a reference c-ring.Additional inspection was conducted on the c-ring and was compared to a reference c-ring.There was objective evidence of damage to the c-ring.Based on the visual evidence, the c-ring, molded nozzle was damaged causing the c-ring to become misshapen.Based on the manufacture engineer results, the reported failure "material twisted/bent- c-ring" was confirmed.The lot # 3000499906 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: 23874022
• Report Number: 2242352-2025-0001314
• Device Sequence Number: 17535532
• Product Code: GEI
• UDI-Device Identifier: 00607567700451
• UDI-Public: (01)00607567700451(10)3000499906(17)270828
• 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): 12/22/2025

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: 3000499906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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