MAUDE Adverse Event Report: LIVANOVA USA INC AORTIC ARCH CANNULAS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	RA-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2020
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.The involved device has been requested for investigation.Device not yet returned.
Event or Problem Description
Livanova usa inc has received a report that, at the end of the procedure, the tip of the aortic cannula disconnected from the body of the cannula.There is not report of any patient injury.
Additional Manufacturer Narrative
Livanova received a report stating that, during a procedure, the tip of the aortic cannula disconnected.The device was not requested as the customer has provided video and photographic evidence of the claimed issue.The dhr review confirmed the complained lot was released conforming to product specifications.Review of the livanova complaint database found one other similar event related to the same lot.No other similar event relevant to the product item code were registered in the previous 12 months.According to standard operating procedure, the tip is manually bonded the tube using uv adhesive (strong bonding agent).Therefore, operator error during the manufacturing of the device (inconsistent application of adhesive) could not be ruled out.To prevent reoccurrence, the manufacturing personal was re-trained and made aware of the customer complaint.As the events are isolated and the risk is in the acceptable region, no other corrective action will be undertaken.Livanova will keep monitoring the market.H3 other text : not requested.
Event or Problem Description
See initial report.

• Brand Name: AORTIC ARCH CANNULAS
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11019095
• Report Number: 1718850-2020-00045
• Device Sequence Number: 3813081
• Product Code: DWF
• UDI-Device Identifier: 00803622105050
• UDI-Public: (01)00803622105050(240)RA-1138(17)220930(10)1925200115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K943934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 09/30/2022
• Device Model Number: RA-XXXXX
• Device Catalogue Number: RA-1138
• Device Lot Number: 1925200115
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/17/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1