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

Model Number 5140-4629

Device Problem Leak/Splash (1354)

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

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

A1., a5., a6.Patient identifier, race and ethnicity were not provided.G3.This report was due on november 24, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.H10.Livanova manufactures the 29fr protekduo.The event occurred in salt lake city, utah.There was no report of patient injury.During follow-up communication, it was reported that the customer used the cannula in a dual drainage configuration and kept central cannulation as the return site.The user performed troubleshooting during the procedure to get better initial flows, however there were not able to determine the source of the bubbles/cavitation.The facility reported that they could not confirm if they were coming from the second drainage cannula (non-livanova device) or from the protekduo.The user facility reported that the involved cannula was kept following the event and the device has already been returned to livanova.While the investigation is anticipated, it has not yet been completed.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 that a patient was implanted with 29fr protekduo via an lvad insertion and the user reported difficult placement and difficult to achieve the desired flows.Upon initiating flows, the user reported seeing air bubbles under echo in the right side of the heart.There was suspicion of a crack in the cannula causing air entrainment or cavitation from femoral and ra drainage.A femoral cannula along with the protekduo were used as drainage while return cannulation was placed surgically in the chest.The patient continued to improve and was supported until (b)(6) 2023 when the decision was made to remove the protekduo and continue lvad and rvad support peripherally.There was no report of patient injury.

Manufacturer Narrative

The complained device was returned to livanova for evaluation.The cannula was returned without shipping fluid.Visual inspection of the cannula noted some kinking at the y-connector to proximal body junction, the proximal basket, and the transition region to distal body junction.It cannot be determined which damage, if any, was present during insertion or use of the cannula, and which damage occurred during re-packaging and return shipment due to coiling of the cannula in its return shipment container.The slight kinking at the proximal basket may have contributed to difficulty advancing the cannula during insertion if it occurred during use.A functional evaluation was performed.An air leak test was performed on the proximal and distal lumens of the cannula.The lumen was then pressurized by depressing a syringe plunger.The pressure gauge was monitored for evidence of leaks.The distal lumen held a pressure of 285 mmhg without evidence of any leaks.The proximal lumen held a pressure of 135 mmhg.Proximal lumen pressure was initially higher but slowly decayed due to an incomplete seal at the latex tubing.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.All tests and inspections were completed with passing results.No specific failure of the device during support was reported, however users requested that an investigation of the complaint device be performed to verify if any fault was present based on the observations during insertion.A crack in the cannula could not be confirmed and no leaks were identified.No reasonable cause for the reported bubbles/cavitation could be identified based on the received complaint information and investigation results.As a specific root cause was not determined, no corrective actions were identified.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: 18247459
• MDR Text Key: 329494365
• Report Number: 2531527-2023-00038
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00814112020166
• UDI-Public: (01)00814112020166(17)250822(11)220822(10)358485
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 5140-4629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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 Age: 42 YR
• Patient Sex: Male
• Patient Weight: 75 KG