MAUDE Adverse Event Report: LIVANOVA USA INC EASYFLOW DUO CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number DUO CANNULA

Device Problem Sharp Edges (4013)

Patient Problem Vascular Dissection (3160)

Event Date 12/28/2020

Event Type  malfunction  

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 obtained, it will be provided in a supplemental report.Device was accidently thrown out.

Event Description

Livanova inc has received a report that, during the cannulation of a re-do patient, the tip of the cannula went straight through the aorta and the aorta dissected.The surgeon felt that the end of the cannula was too sharp.The complained cannula was mistakenly thrown out.There is no report of any patient injury.

Manufacturer Narrative

Livanova received a report that, during a the cannulation, the surgeon felt that the end of the cannula was too sharp.The complained cannula was not not available for investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.A complaints database analysis revealed that no previous complaints were submitted about this specific issue on the same lot.Based on investigation of other previous cases, the two most probable root causes are manufacturing deficiency or inadequate user technique during insertion of the cannula.As the complained cannula was not available, manufacturing issue cound not be ruled out.As the risk has been assessed as acceptable and this an isolated case, no corrective action will be undertaken.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: EASYFLOW DUO CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11221586
• MDR Text Key: 228423216
• Report Number: 1718850-2021-00023
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622124198
• UDI-Public: (01)00803622124198(240)103-210(17)220531(10)1913400005
• Combination Product (y/n): N
• PMA/PMN Number: K091542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: DUO CANNULA
• Device Catalogue Number: 103-210
• Device Lot Number: 1913400005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1