MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) LIVEWIRE? ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE; CATHETER, ELECTRODE RECORDING

Model Number 401904

Device Problem Insufficient Information (3190)

Patient Problems Atrial Flutter (1730); Atrial Tachycardia (1731); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 09/08/2014

Event Type  Injury  

Event Description

Related manufacturer reference 2030404-2014-00093, 3005188751-2014-00116 during a ventricular tachycardia ablation procedure, a pericardial effusion occurred.A livewire duo-decapolar ep catheter was placed in the coronary sinus and a safire blu ablation catheter was placed in the right atrium through a fast cath swartz guiding introducer.Two atrial tachycardias were induced as well as typical atrial flutter, so it was decided to ablate the cavotricuspid isthmus to treat the atrial flutter.Once a bidirectional block was achieved across the isthmus, an additional atrial tachycardia was mapped in the right atrium.The patient then became hypotensive and a pericardial effusion was noted on ultrasound.A pericardiocentesis was performed, which stabilized the patient.There were no performance issues with any sjm device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, vascular perforation is a known risk during the use of this device.

• Brand Name: LIVEWIRE? ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4146188
• MDR Text Key: 15814497
• Report Number: 3005188751-2014-00117
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK022380
• 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: 09/08/2014

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: 401904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/06/2014
• 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
• Treatment: SAFIRE BLU ABLATION CATHETER; FAST CATH SWARTZ GUIDING INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80