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

Model Number 5140-4629

Device Problem Restricted Flow rate (1248)

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

Event Date 03/18/2022

Event Type  Injury  

Event Description

Livanova received report of limited flows from 29fr protekduo cannula after successful insertion, without issue.When connecting to cardiohelp circuit, the inflow into the pump was limited to 0.5-1 liter per minute confirmed by high venous pump line pressures, so concern was for proximal lumen of cannula.The customer reported back bleeding the cannula fine, and even flushing both lumens without issue to troubleshooting and reconnected to circuit with no improvement.Users reported act 380 at the time of cannula insertion and clinicians dismissed clotting as a possibility.When pump and circuit was connected to cannula there was very limited flow.They report adding an additional femoral venous cannula and y-ing it into circuit resulting in good flows.It was reported keeping the cannula in place and eventually clamping off the proximal lumen of the cannula.Patient was maintained with cannula during support until april 5, 2022 when patient had lung transplant and cannula was explanted.There was no report of patient injury.Patient details: patient with respiratory failure secondary to interstitial lung disease.Cannulated as bridge to lung transplant, transplant received and cannula was explanted.

Manufacturer Narrative

There was no patient involvement.Cardiac-assist inc.Manufactures the protek duo veno-venous cannula.The incident occurred in (b)(6).Through follow-up communication livanova learned that no damage/defect of the cannula was noticed by the customer upon removal.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: a medical assessment of the event has been performed.Result of the assessment was that an additional cannula was inserted because of no flow on protekduo cannula.Cannula replacement can be considered a standard practice in this situation.The cannula was returned to the manufacturer site for investigation.Visual inspection of the returned cannula showed a large buildup of dark red biological material in the proximal lumen visualized in proximal extension tube and at the sideholes further down the cannula.It is therefore assumed that the rest of the proximal lumen, obscured by the wire wrapping, was also at least partially full of biological material.The flush test of the proximal lumen corroborates this assumption because the injected water did not flow freely through the cannula; however, the water did make its way from the proximal end of the lumen to the sideholes at the end, indicating that the blockage was not complete.It cannot be determined from the information available whether the blockage of the proximal lumen seen in the returned device was the cause of the initial reduced flow reported by users, however this is considered unlikely due to the high patient act during insertion and the fact that the cannula was backbled and flushed without issue during initial connection and reconnection to the ecmo circuit.It is considered more likely that the buildup in the proximal lumen occurred during support because the lumen was clamped and therefore the blood therein remained stagnant for up to the eighteen days of support.The proximal lumen blockage could also have formed during return shipment of the product, as the device was not flushed before return and was not packaged with any fluid to prevent residual blood from drying.Finally, any blood remaining in the proximal lumen from return shipment was likely further fixed by the formalin treatment applied at the start of return analysis.The cause of the original perceived resistance of the proximal lumen cannot be determined through post-use analysis.Possible causes of reduced flow through the proximal lumen include: - malpositioning of the proximal sideholes or - inadequate vessel size.Because the proximal lumen is used for drainage, it is under negative pressure when connected to an ecmo circuit.If the sideholes are placed in such a position that they are occluded by surrounding tissue, either due to location or inadequate vessel size, blood flow through the proximal sideholes is extremely reduced.However, because there is no negative pressure sucking the surrounding tissues against the proximal sideholes when backbleeding or flushing the cannula, there is no perceived blockage in those cases, consistent with the reported complaint.As per protekduo instruction for use, the user is required to ensure that the vessel size is adequate to accommodate the protekduo cannula and introducer.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
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 14373674
• MDR Text Key: 291494119
• Report Number: 2531527-2022-00024
• 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,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5140-4629
• Device Catalogue Number: 5140-4629
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 70 KG