MAUDE Adverse Event Report: CARDIACASSIST INC. PROTEK DUO VENO-VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 5140-4629

Device Problem Material Twisted/Bent (2981)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 08/02/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Cardiacassist inc.Manufactures the protek duo veno-venous cannula.The incident occurred in (b)(6).Through follow-up communication livanova learned that a dilator set was used prior to inserting the cannula.The dhr for 29fr protekduo lot 244343 was reviewed and no deviations or nonconformances relevant to the reported issue were found.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a protek duo veno-venous cannula kinked in right ventricle (rv).After a few attempts the rv was torn and patient had to emergently have chest opened due to tamponade and cardiac arrest.Rv was sutured but patient was put on central rvad ecmo with another cannulation strategy and protek placement was aborted.Three (3) days later, the patient was brought back to operating theatre and protek duo cannula was successfully placed.Currently, the patient is on support and stable.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 10481281
• MDR Text Key: 205286821
• Report Number: 2531527-2020-00026
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5140-4629
• Device Lot Number: 244343
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/02/2020
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other