MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT PL (PEELABLE) OUTER GUIDE CATHETER

Model Number 410171

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

Patient Problems Death (1802); Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 01/20/2016

Event Type  Death  

Event Description

It was reported that the patient had presented to the hospital for a system implant procedure.During the implant procedure, the physician attempted to gain access to coronary sinus and implant the left ventricular lead but the catheter perforated the patient which caused cardiac tamponade.The physician quickly placed an atrial lead to get av pacing support and attempted multiple times to perform a pericardiocentesis but was unsuccessful.During the attempts, the physician performed cardiopulmonary resuscitation efforts but the patient was in ventricular fibrillation and deceased.The physician suspected that the patient deceased from cardiac tamponade.The cause of death was not confirmed.No additional information was available at this time.

• Brand Name: CPS DIRECT PL (PEELABLE) OUTER GUIDE CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5390966
• MDR Text Key: 36848109
• Report Number: 2017865-2016-00508
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061710
• 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: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 410171
• Device Lot Number: 5087356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2015
• 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: 81 YR