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

Model Number 5140-5131

Device Problem Material Deformation (2976)

Patient Problem Cardiac Perforation (2513)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

Cardiaassist inc.Manufactures the protek duo veno-venous cannula 31 fr.The incident occurred in (b)(6).Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that during insertion of a protek duo protek duo veno-venous 31fr cannula, the wire recoiled into ventricle causing cannula to perforate right ventricle.The surgeon repaired ventricle and left the cannula inserted for patient support.

Event Description

See initial report.

Manufacturer Narrative

Through follow-up communication livanova learned that the wire used during procedure was not a livanova accessory.The reported event is not related to livanova product and therefore has been re-assessed as non reportable.

• 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: 11271815
• MDR Text Key: 230017680
• Report Number: 2531527-2021-00011
• 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: 02/03/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1