MAUDE Adverse Event Report: LIVANOVA USA INC CANNULAE, AORTIC ROOT LONG NEEDLE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	AR-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
4 aortic root cannula units item ar-17014 (1 used unit and 3 unused units), all belonging to same batch of the complained cannula device, were returned to livanova from the customer.Visual inspection of the used cannula confirmed the disconnection of the connector from the needle.Deeper inspection of the connector revealed small amount of adhesive pooled on one side.Visual inspection of the unused cannula units confirmed the correct position of the connector on the needle and revealed similar pooling of the adhesive to one side of the connector.However, manual pull test confirmed the connectors could not separate from the needles.A review of the dhr did not identify any deviation, non-conformity or material issue relevant to the reported failure.Livanova investigation confirmed the reported disconnection.Livanova believes the disconnection was ascribable to an operator error while distributing of adhesive between connector and needle.A dedicated session of training will be performed with the manufacturing operators involved in the production of cannulae ar-17014.This type of failure has a low probability to cause a risk for the surgeon while removing detached guidewire cause.The failure it is not likely causing any serious injury to patient if it were to reoccur.
Additional Manufacturer Narrative
Patient information was not provided.The involved device has been requested for return to livanova for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.
Event or Problem Description
Livanova received a report that, after the insertion of the aortic root cannula in the aorta, the plastic cap that helps to extract the internal guidewire detached from the guidewire.The surgeon could remove the guidewire with the help of a tool.There was no report of patient injury.The user believes this might cause a risk for the surgeon while removing detached guidewire.On the same date, a similar event occurred while using a cannula of the same lot of the present report (livanova reference (b)(4)).

• Brand Name: CANNULAE, AORTIC ROOT LONG NEEDLE
• 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: 8844698
• Report Number: 1718850-2019-00011
• Device Sequence Number: 3147267
• Product Code: DWF
• UDI-Device Identifier: 00803622103094
• UDI-Public: (01)00803622103094(240)AR-17014(17)220228(10)1905000115
• 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): 10/04/2019

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: 02/28/2022
• Device Model Number: AR-XXXXX
• Device Catalogue Number: AR-17014
• Device Lot Number: 1905000115
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1