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

Model Number	VH-2400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw (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 leg of the vasoview 6 pro c-ring is broken.There was a kink, after which the fixation on the ring also broke.The fixation area was very thin and the kink shouldn't be there; the product had not yet been used.The c-ring and retrieval device were not advanced during initial insertion under endoscopic visualization.No parts of the c-ring assembly were caught in the jaws of the retrieval device during the retrieval procedure.No portion of the c-ring become dislodged from the retrieval cannula and lodged in the patient.There was a procedural delay.A new package was opened.The complaint was discovered before the product was put into use; this had no consequences for the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,g3,g6,h2,h3,h11.Previous emdr h3 states "no" since only a partial return was made.The alleged device reported was not returned, hence an evaluation cannot be performed on the alleged device.
Additional Manufacturer Narrative
Tw # (b)(4) updated sections: b4,d9,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 01/28/2026.An investigation was conducted on 01/29/2026.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The reported device vv 6 pro was not returned for evaluation, however, a cannula was returned for evaluation.The c-ring was observed to be intact.The scope wash tube was observed to be cut and melted at the base of the intact c-ring.No other visual defects were observed.Based on the returned condition of the device as well as the evaluation results, the fallure "break- scope c-ring" for the vv6 pro was not confirmed due to the non-return of the reported device, however, the analyzed failure "break- scope wash"- cannula was observed.The lot # 3000488640 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 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: 23780911
• Report Number: 2242352-2025-0001293
• Device Sequence Number: 10091375
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: (01)00607567700239(10)3000488640(17)270627
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2025

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
• Device Lot Number: 3000488640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 02/12/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/11/2026; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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