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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2022
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.Follow up with the customer clarified the patient was not affected, no bleeding was reported, and the complained cannula is available.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc has received a report that the tip of the aortic disconnected from the body of the cannula at the end of a surgery there is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.The complaints history was reviewed, and no similar event was identified related to the same lot.The involved unit was returned to the manufacturer's site according to standard operating procedure, uv adhesive shall be applied to the inside surface of the cannula's distal end and the bonding surface of the curved tip.Visual inspection of the returned cannula found no uv adhesive ring present at the end of the tip.When the tip was pulled out, there appeared to be no adhesive at all.The most probable root cause of the disconnection was a manufacturing error.The manufacturing personnel will be involved in a dedicated training the risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15415982
• Report Number: 1718850-2022-00052
• Device Sequence Number: 6722137
• Product Code: DWF
• UDI-Device Identifier: 00803622105050
• UDI-Public: (01)00803622105050(240)RA-1138(17)230531(10)2013900052
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K943934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: 05/31/2023
• Device Model Number: RA-XXXXX
• Device Catalogue Number: RA-1138
• Device Lot Number: 2013900052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown