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

Catalog Number 5140-5131

Device Problem Malposition of Device (2616)

Patient Problem Tachycardia (2095)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Device lot number was not provided, so udi and expiration date could not be determined.As lot number is unknown, manufacture date could not be determined.Livanova manufactures the protekduo 31fr cannula.The reported event occurred in (b)(6).Patient reportedly suffered from covid-19, which can lead to arrhythmias.The facility reported that the arrhythmias were likely a result of covid-19, critical illness, and cannula positioning.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report from the theme clinical study that a patient experienced multiple runs of non-sustained ventricular tachycardia (nsvt) during a procedure utilizing a protekduo 31fr cannula.The nsvt events occurred intermittently over a number of days, suspected due to cannula position.Patient was put on amiodarone which improve the condition and was discontinued after a few days.

Manufacturer Narrative

As the patient suffered from covid-19 and the event occurred 9 months prior to it being reported to livanova, the device was not made available for investigation.However, it is known that covid-19 disease can contribute/lead to a risk of nsvt and cardiac episodes.Based on all available information, the most likely root cause of the reported event is patient-related.A malfunction of the protekduo cannula could not be confirmed.The lot number of the device was not provided, so a dhr review could not be performed.As an exact root cause could not be determined, no specific corrective action has been identified.The facility reported that the arrhythmias were likely a result of covid-19, critical illness, and cannulation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• 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: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 15792927
• MDR Text Key: 303622937
• Report Number: 2531527-2022-00052
• 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: Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 5140-5131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention