MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE

Model Number 401575

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Related mfr report number: 2182269-2016-00034.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.A non sjm ice catheter was inserted into the heart prior to any other devices and initial imaging noted a pre-existing pericardial effusion.A livewire catheter was inserted into the coronary sinus, transseptal access was obtained, and a reflexion spiral catheter was advanced into the left atrial appendage.While attempting a second transseptal access, the patient became hypotensive and an intracardiac echocardiogram revealed the pericardial effusion had increased in size.A pericardiocentesis was performed which stabilized the patient.It was suspected the effusion was due to a perforation of the coronary sinus or the left atrial appendage.There were no performance issues with any sjm devices.

Manufacturer Narrative

The results of the investigation concluded that the device met sjm specification requirements of acceptable resistance values with no open or short circuits.The catheter also displayed acceptable signals during an ecg simulation.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.The cause of the reported pericardial effusion could not be confirmed and remains unknown.Per the ifu, vascular perforation a known risk during the use of this device.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 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: 6155403
• MDR Text Key: 61806297
• Report Number: 2182269-2016-00033
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913940
• 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,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 401575
• Device Lot Number: 5646578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• 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: BIOSENSE WEBSTER ICE CATHETER; REFLEXION SPIRAL CATHETER; SL0 INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR