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

Model Number 5140-5131

Device Problem Crack (1135)

Patient Problem Hemolysis (1886)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Cardiac-assist inc.Manufactures the protek duo veno-venous cannula.The incident occurred in (b)(6).A picture of the cannula was provided and analyzed.The cannula appeared to be completely fractured at the distal side of the transition region.The wire wrapping is exposed and the breach extends to the lumen.The cannula fracture is hypothesized to be due to placement of the transition region in the right ventricle.The configuration places the cannula in a "u" shape and therefore the damage at the transition region is likely due to cyclic loading from repeated right ventricle contraction during support.In this case, the cannula kink was not detected until the explant and did not impact the use of the device.Based on the current level of information, it cannot be excluded that the reported event may have contributed to the reported hemolysis.The instruction for use, 7000-0155 rev 10, contains a warning regarding kinking.Section 2, warnings and precautions item 13 states the following: "avoid kinking the protek-duo 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".

Event Description

Livanova received report that on a covid-19 positive patient was removed from ecls support after an unknown length of time.The site reported some degree of hemolysis towards the end of support.The protek duo cannula was removed and was noted to be cracked upon removal.The patient was decannulated due to recovery and was no longer in need of support.

• 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: 10100013
• MDR Text Key: 194344150
• Report Number: 2531527-2020-00017
• 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
• Report Date: 05/27/2020

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: 5140-5131
• Device Catalogue Number: 5140-5131
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/29/2020
• 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