MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SUPREME¿ ELECTROPHYSIOLOGY CATHETER; DIAGNOSTIC EP CATHETERS

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

Patient Problem Cardiac Perforation (2513)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

An event of 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 cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Additional manufacturer: 2030404-2017-00057, 2182269-2017-00150.During a left ventricular ablation procedure a pericardial effusion occurred.The patient became hypotensive during the procedure and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott devices.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: DIAGNOSTIC EP CATHETERS
• 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: 7138138
• MDR Text Key: 95494310
• Report Number: 2182269-2017-00151
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K002976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2017

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: 12/14/2017
• Initial Date FDA Received: 12/21/2017
• 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: LIVEWIRE CATHETER; THERAPY COOL PATH CATHETER
• Patient Outcome(s): Required Intervention
• Patient Weight: 84