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 01/29/2016

Event Type  Death  

Event Description

The patient was a (b)(6) male transferred from an outlying facility post mi.Placed on va ecmo initially then transitioned to vv support using protek duo.Patient was awake and alert on the 11th day of support when he suddenly grabbed his chest, collapsed, and could not be resuscitated.The autopsy report indicated a perforation of the right ventricular wall near the pulmonic valve and an associated dissection of the heart muscle.Nearly three liters of blood were found in the patient's chest.The dissection and hemorrhage were the apparent cause of death.

• Brand Name: PROTEK DUO
• 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
• MDR Report Key: 5460018
• MDR Text Key: 38992032
• Report Number: 2531527-2016-00002
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2016

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: 04/01/2016
• Device Model Number: 5140-4629
• Device Catalogue Number: 5140-4629
• Device Lot Number: AMO53199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 56 YR