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 Problem Cardiac Perforation (2513)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Manufacturing related reference: 9680001-2018-00003, 2182269-2018-00011.During a pulmonary vein isolation procedure, a pericardial effusion occurred.Following several lesions, the patient became hypotensive and an ice catheter confirmed a posterior pericardial effusion.The patient was observed in the lab for 30 minutes, pressure resolved and the effusion improved.No intervention was necessary and the patient left the lab in stable condition.There were no performance issues with any abbott devices.

• 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: 7203052
• MDR Text Key: 97650937
• Report Number: 2182269-2018-00012
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• 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: 01/04/2018
• 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: BIOSENSE ICE CATHETER; REFLEXION SPIRAL EP CATHETER; TACTICATH ABLATION CATHETER
• Patient Outcome(s): Other