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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw id#(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
The hospital reported that during several cases, vasoviewhempro vh-3500 silicon coating of the jaws appeared to heat up and begin to peel and come loose.Harvester takes out the jaws and removes the piece that has come loose or begun peeling.There has been no patient harm.
Additional Manufacturer Narrative
Trackwise#:1096360.Updated sections: b4, b5, g3, g6, h2, h6, h11.Corrected sections: h6--health effect ¿ impact codes.A lot history record review was completed for lots 3000351376, 3000402378, and 3000389329 the last 3 lots shipped to the account prior to the event/aware date.For lot # 3000351376.There were 4 ncmrs , rework, or deviations documented for the lot number.For lot 3000402378.There were three ncmrs, rework, or deviations documented for the last 3 lots shipped to the account for lot 3000389329- there was one (01) ncmrs , rework, or deviations documented for the 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
The hospital reported that during several cases, vasoviewhempro (b)(6) silicon coating of the jaws appeared to heat up and begin to peel and come loose.There were no pieces that detached into patient or tunnel.Harvester takes out the jaws and removes the piece that has come loose or begun peeling.There were no instances of needing to make a larger incision.The same device was used to complete the procedure.Sometimes, the device was taken out of the tunnel to manually pull the piece off that was starting to come loose so that it didn't fall into the tunnel.There was a delay of a few seconds to pull the loose pieces from the jaw.There was no patient harm.

• 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: 20050145
• Report Number: 2242352-2024-00957
• Device Sequence Number: 20823121
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/25/2024

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 Model Number: VH-3500
• Device Catalogue Number: VH-3500
• 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: 08/03/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/10/2024
• 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: UNKNOWN.
• Patient Sex: Unknown