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

Model Number	VH-2004
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported vv 6 accessory pack had plastic shavings in the conical tip.The case was completed using the tip.No patient injury.Related to tw (b)(4).
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.
Event or Problem Description
The hospital reported vv 6 accessory pack had plastic shavings in the conical tip.They found that one of the scopes was damaged and had a burr on the end of it.It is suspected that the damaged scope created the situation outlined here and scraped the inside of the conical tip causing the plastic filament to be created.The case was completed using the tip.No patient injury.
Additional Manufacturer Narrative
Trackwise#: (b)(4).
Additional Manufacturer Narrative
Tw # (b)(4).Corrected section: h6 problem code changed to 2930.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Updated section: b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 09/25/2024.An investigation was conducted on 10/09/2024.A visual inspection was conducted.There were no visual defects observed on the intact conical dissection tip.An image quality inspection was performed with an endoscopic video imaging system.A clear image was able to be obtained, however there were scratches observed in the image.No other visual defects were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "environmental particulates" was confirmed.The lot # 3000407465 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 EVH ACCSESSORY PACK
• 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: 20334337
• Report Number: 2242352-2024-0001072
• Device Sequence Number: 8003740
• Product Code: GEI
• UDI-Device Identifier: 00607567700376
• UDI-Public: (01)00607567700376(10)3000407466(17)260708
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K041981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/20/2025

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 Expiration Date: 07/08/2026
• Device Model Number: VH-2004
• Device Catalogue Number: VH-2004
• Device Lot Number: 3000407466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 12/09/2024; 02/20/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/25/2024; 01/03/2025; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male