MAUDE Adverse Event Report: CARDIACASSIST INC PROTEK DUO VENO-VENOUS CANNULA

Model Number 5140-4629

Device Problem Malposition of Device (2616)

Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 04/15/2016

Event Type  Death  

Event Description

The patient was a middle aged male who developed severe rv failure 10 days following lvad placement.Approximately 30 minutes following insertion of the protekduo and initiation of support, flows on the lvad suddenly dropped along with flows on the protekduo/tandemheart circuit.The patient's blood pressure also suddenly dropped significantly.Cpr was performed and the patient was placed on percutaneous v-a ecmo with a separate circuit.The patient's chest was opened for exploration and a large amount of blood was noted in the chest cavity.Resuscitative measures were unsuccessful and the patient exsanguinated.A tear described to be a few centimeters long was discovered extending from the main pulmonary artery down into the rvot.None of the associated equipment was kept for inspection or analysis.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Type of Device: VENO-VENOUS CANNULA
• Manufacturer (Section D): CARDIACASSIST INC; 240 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC; 240 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: greg johnson ; 240 alpha drive; pittsburgh, PA 15238 ; 4129637770
• MDR Report Key: 5654315
• MDR Text Key: 45161170
• Report Number: 2531527-2016-00009
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2016

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: Physician
• Device Expiration Date: 12/23/2018
• Device Model Number: 5140-4629
• Device Catalogue Number: 5140-4629
• Device Lot Number: AMO60635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• 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
• Treatment: LVAD
• Patient Outcome(s): Death
• Patient Age: 50 YR