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

Model Number 5140-5131

Device Problem Malposition of Device (2616)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/04/2017

Event Type  Death  

Manufacturer Narrative

An autopsy revealed the distal tip of pd cannula physically protruding 3 inches outside of rv outflow tract demonstrating physical puncture of heart structure with cannula.No equipment was kept for inspection or analysis.

Event Description

A post durable lvad patient was brought to the cardiac cath lab on (b)(6) 2017 for insertion of a protek duo cannula.The duo was placed and support was initiated without incident.The patient had been on support for about twenty minutes when vt was noted.Upon visualization under fluoroscopy, cannula distal tip was noted to have moved from the original pa position into the rv.With support continuing, the physician attempted to "slightly" re-engage distal tip of cannula into pa via cannula only manipulation.Patient became unstable and resuscitation efforts were attempted without success.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• 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: 6522566
• MDR Text Key: 73723919
• Report Number: 2531527-2017-00003
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160257
• 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: 04/26/2017

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: 5140-5131
• Device Catalogue Number: 5140-5131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 04/26/2017
• 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