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

Model Number	VH-3500
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 vasoviewhempro vh-3500 tips were uneven.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated section: b4, b5, g3, g6, h2, h6, h10.
Event or Problem Description
The hospital reported that during preparation for an endoscopic vessel harvesting procedure, vasoviewhempro vh-3500 tips were uneven.A new device was used to perform the procedure.There was no delay.There was no patient involvement.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The lot # 3000382054 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.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h11.Corrected sections: d4--unique identifier (udi) # corrected from (b)(4).H6--component codes corrected from "3123" to "1028".The device was returned to the factory for evaluation on 09/06/2024.An investigation was conducted on 09/30/2024.A visual inspection was conducted.Both the harvesting device and cannula was returned for evaluation.There were no visual defects observed on the intact cannula or intact c-ring.There were no visual defects observed on the intact heater wire.The gray silicone insulation on both the cold and hot jaws was observed to be intact.The gray cold jaw insulation on the tip of the cold jaw was observed to be slightly longer than the gray silicone insulation on the hot jaw.An engineer evaluation was conducted.Upon closer investigation it was observed that the jaws were uneven.See figure 1.The cold jaw boot was measured using a caliper (cal id 14067) and the measurement was 0.685 inches which is within specification per rm2047083 rev a.The cold jaw was measured at 1.001 inches which is within specification per rm2047056 rev b.Based on the returned condition of the device as well as the evaluation results, the reported failure "mechanical problem- jaws not aligned" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 3000382054 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.

• 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: 19972391
• Report Number: 2242352-2024-00918
• Device Sequence Number: 7048007
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: (01)00607567701250(10)3000382054(17)250321
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/22/2024

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: 03/21/2025
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000382054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 09/24/2024; 11/22/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/09/2024; 09/24/2024; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown