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	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure while cauterizing tissue on the lower leg, vasoviewhempro vh-3500 silicone piece about 1cm in size broke in the harvesting tunnel.The piece was retrieved with the jaws.No additional incisions were made.A new device was used to complete the procedure.There was an approximate 3 minute delay.There were no further issues.
Additional Manufacturer Narrative
E1 (b)(6).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.
Additional Manufacturer Narrative
Tw#: (b)(4).Updated sections: a3: sex, e1: event site name.Corrected section: d4: unique identifier (udi)# from (b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure while cauterizing tissue on the lower leg, vasoviewhempro vh-3500 silicone piece about 1cm in size broke in the harvesting tunnel.The piece was retrieved with the jaws.No additional incisions were made.A new device was used to complete the procedure.There was an approximate 3 minute delay.There were no further issues.There was no patient harm.
Additional Manufacturer Narrative
Tw # (b)(4).The device was returned to the factory for evaluation on (b)(6)2024.An investigation was conducted on (b)(6)2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the jaws.Charred material was observed on the intact heater wire.There were no visual defects observed on the gray intact silicone insulation on the hot jaw.The gray silicone insulation on the tip of the hot jaw was observed to be peeled and detached from the cold jaw, exposing the cold metal tip.No other visual defects were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "peeled; delaminated; jaw" was confirmed.The lot # 3000351376 history record review was completed.There were (04) ncmrs, rework, or deviations documented for the reported lot number.There were three (03) ncmrs identified which has no relation between the batch manufacturing process and the reported failure, and (01) ncmr which relates to the reported failure.Hhe 1085406 and field action 1101822 address the reported failure described in the ncmr.
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: 20169521
• Report Number: 2242352-2024-01013
• Device Sequence Number: 12522719
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: (01)00607567701250(10)3000351376(17)241029
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2025

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: 10/29/2024
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000351376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 02/13/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/17/2024; 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0092-2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female