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

Catalog Number 5140-5131

Device Problem Restricted Flow rate (1248)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

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 thrombosis.The customer reported that the day following the event, heparin-induced thrombocytopenia antibody was ordered and the patient was switched to argatroban for covid-19 hypercoagulability.There is no known malfunction of the protekduo cannula in relation to this event.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.H3 other text : device not available for return.

Event Description

Livanova received a report through the theme clinical study that clots were noted in the protekduo 31fr cannula during a procedure.The clots were reportedly abnormal in color, a very dark red, and were noted from the insertion site down to the y.Past the y, the color was brighter red.Flows suddenly began to drop from 2.5 to 1.0 to 0.2lpm.Patient was anticoagulated.The line was clamped off and the patient was sent to the cath lab for bilateral femoral cannulation.The protekduo cannula was removed and a proteksolo was inserted in its place.There was no report of patient injury as a result of the cannula clots.

Manufacturer Narrative

H.10.The device was not made available for return.Covid-19 disease can contribute/lead to clotting formation due to a higher incidence of coagulopathy and thrombosis.The decrease in cannula performance and clotting may have been due to accumulation of biological deposits within the cannula leading to a reduction of flow through the device.Based on all available information, the reported issue is most likely not device related and instead associated to patient conditions.The serial/lot number of the device was not provided, so a review of the dhr could not be completed.Taking into account all the above facts, the most likely root cause of the reported event is patient-related and a device malfunction can be excluded.No other specific action has currently been deemed necessary.Livanova maintains and documents periodic customer events monitoring in order to evaluate actions for product improvement.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: 15793342
• MDR Text Key: 307997672
• Report Number: 2531527-2022-00051
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 11/16/2022
• 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