MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONIT; CATHETER, PERCUTANEOUS CARDIAC ABLATION

Model Number 402840

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

Patient Problem Cardiac Perforation (2513)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was unable to be reviewed since the batch number is unknown.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, vascular perforation is a risk of any electrode placement.

Event Description

Related manufacturer reference 2030404-2015-00060 during a pvc ablation procedure, a pericardial effusion occurred.A safire tx catheter was used to perform mapping in the left ventricle and one ablation was performed with a safire blu ablation catheter.A non-sjm ice catheter then revealed a pericardial effusion.A pericardiocentesis was performed and no further intervention was required.There were no performance issues with any sjm device.

• Brand Name: SAFIRE¿ TX BI-DIRECTIONAL ABLATION CATHETER 8 MM TIP UNIVERSAL TEMPERATURE MONIT
• Type of Device: CATHETER, PERCUTANEOUS CARDIAC ABLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5005321
• MDR Text Key: 23087216
• Report Number: 2030404-2015-00059
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/17/2015

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
• Device Model Number: 402840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• 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: UNKNOWN SL INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Weight: 99