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 Cardiac Tamponade (2226)

Event Type  Injury  

Manufacturer Narrative

Serial/lot number is unknown.This information will be provided in a supplemental report if made available.As the serial/lot number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Cardiac assist inc.Manufactures the xprotek duo veno-venous cannula.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device discarded by the customer.

Event Description

Livanova received report that protekduo 29 fr cannula had been kinked in the right ventricle (rv) and the internal coil embedded itself in the rv causing erosion at the apex.When the patient was decannulated, the cannula tore a hole in the apex of the rv and the patient tamponaded.

Event Description

See initial report.

Manufacturer Narrative

H10: through follow up communications livanova learned that the patient was cannulated for multiple weeks and was then transferred to a different hospital.In addition, it was communicated that no issue occurred during cannulation phase and that the patient was cannulated for multiple weeks.Based on the information currently available, it cannot be ruled out that the most likely root cause of the reported cannula kink was the movement of the patient from one hospital to another.

• 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: 11790386
• MDR Text Key: 249470170
• Report Number: 2531527-2021-00017
• 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: 05/07/2021

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: 5140-4629
• Device Catalogue Number: 5140-4629
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR