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	Foreign Body In Patient (2687)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tw id# (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.
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure, vasoviewhempro vh-3500 entire piece of the jaw broke off inside patient.The harvester was able to use the jaws of the cutting tool to retrieve the piece and pull it out of the tunnel, and no other parts/pieces fell into the patient.A new device was opened to complete the case.There was a procedural delay.There was no patient harm.Photo provided by complainant shows the device with evidence of blood with a piece of silicone detached from the jaws.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 07/26/2024.A photograph was provided by the account.Signs of clinical use and evidence of charred material were observed.The heater wire was observed to be intact with no visual defects.The gray silicone insulation was observed to be entirely detached from the cold jaw and is separate from the device.A piece of silicone insulation along the heater wire of the hot jaw was observed to be peeled and between the jaws.An investigation was conducted on 8/8/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed.The heater wire was observed to be intact with no visual defects.The gray silicone insulation was observed to be entirely detached from the cold jaw and was returned separately for evaluation.A thin piece of silicone insulation along the heater wire of the hot jaw was observed to be peeled and detached.The detached insulation was returned between the jaws.Based on the returned condition of the device, photo evaluation, and results of the investigation, the reported failure "peeled; delaminated; jaw" was confirmed.The lot # 3000399911 history record review was completed.There were (02) ncmrs , rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results for ncmr # 17985, it was determined that there is no relation between the batch manufacturing process and the reported failure.Based on the dhr/lhr review results for ncmr #17998, it was determined that there is a relation between the batch manufacturing process and the reported failure.

• 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: 19919038
• Report Number: 2242352-2024-00895
• Device Sequence Number: 17953008
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: (01)00607567701250(10)3000399911(17)260606
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2026
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000399911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown