MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ELECTROPHYSIOLOGY (FIXED)

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

Patient Problem Cardiac Perforation (2513)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Related manufacturer reference 3005334138-2017-00004.Following an atrioventricular nodal reentry tachycardia ablation procedure, a pericardial effusion occurred.Following the procedure, the patient became hypotensive and an echocardiogram was performed which revealed a pericardial effusion on the right side of the patient's heart.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any sjm devices.

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, cardiac perforation is a known risk during the use of this device.

• Brand Name: ELECTROPHYSIOLOGY (FIXED)
• Type of Device: ELECTROPHYSIOLOGY (FIXED)
• 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: 6262580
• MDR Text Key: 65207844
• Report Number: 2182269-2017-00009
• Device Sequence Number: 1
• Product Code: MTE
• 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,Followup
• Report Date: 12/19/2016

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• 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: BARD CS CATHETER; BOSTON SCIENTIFIC BLAZER CATHETER; SJM TRANSSEPTAL INTRODUCER; SJM TRANSSEPTAL INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Weight: 50