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

Model Number	VH-3500
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that vasoviewhempro vh-3500 silicone was peeling away from the energy wire.A new device was used to complete the procedure.
Additional Manufacturer Narrative
Tw id#(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.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).The device was returned to the factory for evaluation on 08/26/2024.An investigation was conducted on 09/04/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the intact heater wire.There were no visual defects observed on the intact gray silicone insulation on both the cold and hot jaws.No peeling of silicone was observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "peeled; delaminated; jaw" was not confirmed.The lot # 3000369645 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
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• 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: 20076507
• Report Number: 2242352-2024-00972
• Device Sequence Number: 12365827
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K153194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 Expiration Date: 01/29/2025
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000369645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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: UNKNOWN.
• Patient Sex: Unknown