MAUDE Adverse Event Report: LIVANOVA USA INC ENDOSCOPIC VEIN HARVESTING SYSTEM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIE

Model Number	VC15
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc has received a report stating the tip of the evh catheter broke during a procedure.There is no report of any patient injury.Livanova received the report ref mw5097872.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Livanova received report about an evh system brake inside the patient's leg during procedure.No patient injury was reported.Affected component was not available for product analysis at manufacturer.Review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.No other complaint was received for same lot.Livanova investigation could not address any device related malfunction.Based on available information, suboptimal usage of the device could not be excluded.As no root cause could be identified and risk is acceptable, no corrective action will be undertaken.Livanova will keep monitoring the market.

• Brand Name: ENDOSCOPIC VEIN HARVESTING SYSTEM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIE
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11077170
• Report Number: 1718850-2020-00047
• Device Sequence Number: 14136107
• Product Code: GEI
• UDI-Device Identifier: 00803622132360
• UDI-Public: (01)00803622132360(240)230131(17)VC15(10)2019600029
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K102983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 01/31/2023
• Device Model Number: VC15
• Device Lot Number: 2019600029
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1