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

Model Number 5140-4629

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Cardiac Perforation (2513)

Event Date 10/18/2017

Event Type  Death  

Event Description

Emergent cannulation was attempted in order to support a female patient suffering from post-cardiotomy arrest.The right ventricular outflow tract was perforated during the cannulation, resulting in the patient's 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 ; 4129637770
• MDR Report Key: 7139827
• MDR Text Key: 95546382
• Report Number: 2531527-2017-00005
• 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: 12/21/2017

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 Model Number: 5140-4629
• Device Catalogue Number: 5140-4629
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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