MAUDE Adverse Event Report: LIVANOVA USA INC CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS; CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE

Model Number	AR-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The involved aortic root cardioplegia cannula has been disposed by the customer and thus it is not available for investigation at livanova.A review of the dhr did not identify any deviation or non-conformity 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 in has received a report that, during a procedure, the aortic root cardioplegia cannula necessitate to be modified to remain connected.The customer reported this could have caused hemorrhage.There is no report of any patient injury.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
During follow up information with the customer, it was clarified that the complained issue was a smaller outside diameter of the aortic root cannula which caused the customer to change the whole cannula.Neither the complained cannula was made available nor any picture of the issue was provided.During follow up information with the customer, livanova has been informed that units belonging to the same lot were still available at the customer site.Despite requested, also those units were not returned to livanova.The review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.No other complaint has been recorded for the claimed product lot.The failure reported by the customer could not be assigned to a product problem.The issue claimed by the customer was never encountered in the past and could not be verified due to unavailability of the defective device.Without possibility for device investigation no product failure could be confirmed so no hazardous situation could be confirmed.Livanova will keep monitoring the market.H3 other text : device not available.

• Brand Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Common Device Name: CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10118415
• Report Number: 1718850-2020-00024
• Device Sequence Number: 11224635
• Product Code: DWF
• UDI-Device Identifier: 00803622103018
• UDI-Public: (01)00803622103018(240)AR-11014(17)221130(10)1930800092
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: AR-XXXXX
• Device Catalogue Number: AR-11014
• Device Lot Number: 1930800092
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1