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

Model Number 5140-4629

Device Problem Crack (1135)

Patient Problem Hemolysis (1886)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

There was no patient involvement.Cardiacassist inc.Manufactures the xprotek duo veno-venous cannula.The incident occurred in (b)(6).The device has been requested for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a protekduo cannula in use on patient was removed.Reportedly, the patient was having a lot of hemolysis, and it was noted that the cannula had a fracture.The support was continued using a different cannulation strategy.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the cannula was used for a vv ecmo case which was implanted on may 30th at fransiscan st.Francis in indianapolis.The patient transferred to cleveland clinic a few weeks later.The cannula was in use for 82 days and was placed in the typical ra-pa configuration.The cannula was returned at the manufacturer site and investigated.Investigation results confirmed the crack at the distal part of the cannula near the transition area.The fracture is likely due to cyclic loading from repeated right ventricle contractions during 82 days of support in ra-pa configuration.When the cannula is in this configuration it assumes an "u" shape.When the apex of the bend in the cannula body is located at the junction between the transition region and the distal lumen, the cyclic loading from right ventricle contraction is known to cause damage.As reported in device instruction for use, the user is required to "avoid kinking in the protekduo cannula or introducer during insertion and placement within the patient¿s vasculature.Note: the area of the cannula that tapers from large to small diameter (transition region) is more susceptible to kinking than other areas.Avoid positioning this region with a tight bend radius during support." based on all information collected and product analysis, it is not possible to exclude that the cannula damage could have contributed to the reported hemolysis.However, the cannula damage was due to a prolonged use of the device (82 days) which exceeds the recommended duration of support with protek duo (30 days).

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: 12487877
• MDR Text Key: 271892363
• Report Number: 2531527-2021-00040
• 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
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5140-4629
• Device Catalogue Number: 5140-4629
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention