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

Model Number 5140-5131

Device Problem Migration (4003)

Patient Problems Bradycardia (1751); Asystole (4442)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Cardiacassist inc.Manufactures the protek duo veno-venous cannula.The incident occurred in (b)(6).The dhr for 31 fr protekduo cannula (5140-5131) lot 293308 was reviewed.No nonconformities or abnormalities were found.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that on june 30 it was difficult to visualize the protek duo veno-venous cannula which was inserted on june 28.A cxr was conducted and reportedly it appeared to be in a good position, possibly little low.It was stated that based on anatomy during cannulation, pulmonary artery bifurcation appears to be lower than expected.On july 1, an episode of decreased flow followed by brief asystole was reported.Ecmo catheter was slightly low on cxr and decision was made to convert bi-femoral.Sudden episode of chattering followed later on.Flow went down to 0.8 and then recovered to 3.4 without intervention.10 seconds later, hr and arterial bp declined to 0.Hr and bp also recovered without intervention.Entire episode lasted approximately 30 seconds.Patient chattered again while intensivist group was at bedside to evaluate, flow dropped to 0.6 and then recovered.The patient was bradycardic in 50s and 0.5 mg atropine was given.Precedex drip was discontinued and ketamine infusion was ordered.Hds for 5 mins then vv ecmo chattered then flows dropped to 0 and patient became bradycardic to 20s but improved to 60s s/p atropine dose.Flows recovered independently.Lr 500 ml bolus given and rpm reduced to 4800 from 5000.Cxr ordered and echo were done to evaluate rv outflow track and pulm valve to confirm cannula placement.On july 2, cxr identified that distal tip of protek duo cannula was not in good position.It was decided to proceed with bi-femoral vv ecmo cannulation followed by decannulation of rij protek cannula.Cpr initiated and rosc obtained after administration of epinephrine x 1.Given 0.5mg atropine prior to removal of rij vv ecmo cannula in anticipation of bradycardia with removal.Right neck cannulation vv ecmo has migrated back into the right ventricle, proximal port in right svc.Flows have been reportedly marginal overnight.With drop in flow, patient ecmo dependent, developed hypoxemia and transient asystole.The staff decided to move to cath lab and recannulate, place a new circuit and bilateral femoral catheters.

Manufacturer Narrative

H.10: the cannula was not made available for return, thus no investigation could be performed.Based on the information available and on the fact that no defect of the cannula was mentioned, the most likely root cause of the reported event can be: cannula migration due to patient movements and/or.Cannula not properly secured to the patient.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial 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
• MDR Report Key: 12245453
• MDR Text Key: 268213813
• Report Number: 2531527-2021-00026
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 5140-5131
• Device Catalogue Number: 5140-5131
• Device Lot Number: 293308
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 08/31/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1