MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) SUPREME EP CATHETER, 6F, QUADRIPOLAR, JSN

Model Number 401430

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Anoxia (1711); Death (1802); Ventricular Fibrillation (2130); Pericardial Effusion (3271)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

Related manufacturer reference 3005188751-2014-00018.During a non-emergent left side ventricular tachycardia ablation procedure, the patient developed a pericardial effusion.A fast cath 12 cm hemostasis introducer was placed in the right femoral vein and a supreme ep quad catheter was inserted and advanced into the right ventricle.Ventricular tachycardia was induced with multiple morphologies.A fast cath swartz guiding introducer was placed in the right femoral artery and advanced distal to the aortic arch into the descending aorta.A non-sjm ablation catheter was advanced through the introducer, across the aortic valve, and into the left ventricle.Heparin was administered.Mapping and model creation was initiated; during mapping the patient became hypotensive.A transthoracic echocardiogram revealed a pericardial effusion.Protamine was given and a pericardiocentesis was performed to stabilize the patient.A pericardial drain was placed, all femoral lines were pulled, and the patient was transported to their room in stable condition.The physician indicated no performance issues with an sjm device.An echocardiogram the next morning showed no pericardial effusion.The patient developed ventricular fibrillation during breakfast, for which the existing implanted icd was unsuccessful in returning the patient to normal sinus rhythm.External rescue was attempted and a pulse was successfully restored; however, the patient suffered an anoxic injury and the family terminated rescue efforts and the patient expired.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the info rec'd, the cause of the reported pericardial effusion and death could not be conclusively determined.Per the ifu, cardiac perforation is a known inherent risk during the use of this device.

• Brand Name: SUPREME EP CATHETER, 6F, QUADRIPOLAR, JSN
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 177 east country road b; st. paul, MN 55117 ; 6517564071
• MDR Report Key: 3678619
• MDR Text Key: 4255167
• Report Number: 3005188751-2014-00017
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 401430
• Device Lot Number: 4260517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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: FAST CATH SWARTZ GUIDING INTRODUCER; FAST CATH 12CM HEMOSTASIS INTRODUCER; (406701/LOT UNKNOWN); BIOSENSE WEBSTER EZ STEER THERMOCOOL ABLATION; (406853/LOT UNKNOWN); CATHETER (MODEL/LOT UNKNOWN)
• Patient Outcome(s): Death; Required Intervention
• Patient Weight: 66