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

Model Number	VH-3500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure, vasoviewhempro vh-3500 had a broken tip.A new device was used to compete the procedure.There was no delay.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).Updated sections: b-4, b-5,g-3, g-6, h-2, h-3,h-6, h-11.The device was returned to the factory for evaluation on 08/28/2024.An investigation was conducted on 09/11/2024.A visual inspection was conducted.Both the harvesting device and cannula was returned for evaluation.Signs of clinical use and evidence of blood was observed on both devices.There were no visual defects observed on the intact cannula or intact c-ring.There were no visual defects observed on the intact harvesting device jaws or heater wire.Based on the returned condition of the device as well as the evaluation results, the reported failure "break" was not confirmed.The lot # 3000402378 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
The hospital reported that during an endoscopic vessel harvesting procedure, vasoviewhempro (b)(6) had a broken tip.No components were left inside and no additional incisions were required.A new device was used to compete the procedure.There was no delay.

• 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: 20191181
• Report Number: 2242352-2024-01035
• Device Sequence Number: 8070060
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• 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: 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 Expiration Date: 06/17/2025
• Device Model Number: VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 3000402378
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2023
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 81 KG