MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION? SPIRAL EP CATHETER; ELECTROPHYSIOLOGY (STEERABLE)

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

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Vertigo (2134); Complaint, Ill-Defined (2331); Pericardial Effusion (3271)

Event Date 04/27/2015

Event Type  Injury  

Event Description

Related manufacturer reference 3005334168-2015-00056, 2030404-2015-00044.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.An inquiry ep catheter was placed in the coronary sinus and a reflexion spiral ep catheter was placed in the left atrium.A tacticath quartz ablation catheter was used to perform the ablation procedure.A few hours following the procedure, the patient became hypotensive and pale and complained of vertigo and chest pain.An ultrasound revealed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.There were no performance issues with any sjm device.

• Brand Name: REFLEXION? SPIRAL EP CATHETER
• Type of Device: ELECTROPHYSIOLOGY (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: 4799404
• MDR Text Key: 5832276
• Report Number: 3005188751-2015-00051
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• 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: INQUIRY EP CATHETER; TACTICATH QUARTZ ABLATION CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 74