MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VV 6 ACCESSORY PACK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-2004
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Event or Problem Description
Prior to start of procedure, the purple dissection tip was removed from kit and it was noticed that the tip was not smooth and appeared to have ridges.Picture was provided by hospital.The tip was not used for procedure, a new accessory kit was opened.Tip was discarded by account.Patient information n/a as it was not used on a patient.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,e1,g3,g6,h2,h6,h11.The device was not returned to maquet cardiac surgery for investigation; however, a photograph was provided by the account.A photographic evaluation was conducted.Signs of clinical use and no evidence of blood was observed.The side of the dissection tip was observed to be not smooth just above the ridges on the dissection tip.No other visual defects were observed in the photograph.Based on the non-return of the device as well as the photographic evaluation, the reported failure "defective component" was confirmed.A manufacturing engineering evaluatuoin was conducted on the photograph provided by the account.The device was not returned to maquet for investigation; however, a photograph was provided by the account.A photographic evaluation was conducted.No signs of clinical use or evidence of blood was observed on the dissection tip.The dissection tip was observed to have a defect that appeared as ridges and affected the surface smoothness.No other visual defects were observed in the photograph.Based on the photographic evaluation, the reported failure "defective component" was confirmed.A supplier investigation was conduted based on the photograph provided by the account.The supplier stack plastics (from which this dissection tip originates) no longer existsand has been replaced by springboard manufacturing.The representative from springboard noted that they do not have enough information from the stack plastics production run which encompassed the lot above to come to a conclusion about the origin of the failure.Additionally, the supplier mentioned that from a singular image and the lack of a physical sample, it is challenging to come up with a conclusion of the defect¿s origin.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.A lot history record review was completed for lot 3000358119 and the last lot shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last lot shipped to the account.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: VV 6 ACCESSORY 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: 23543677
• Report Number: 2242352-2025-0001203
• Device Sequence Number: 9322823
• Product Code: GEI
• UDI-Device Identifier: 00607567700376
• UDI-Public: (01)00607567700376
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 11/12/2025

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 Model Number: VH-2004
• Device Catalogue Number: VH-2004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NO.
• Patient Sex: Unknown