MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ BLU¿ ABLATION CATHETER; IRRIGATED ABLATION CATHETER

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

Patient Problems Bradycardia (1751); Nausea (1970); Pericardial Effusion (3271)

Event Date 07/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, vascular perforation or dissection is an inherent risk of any electrode placement.

Event Description

Related manufacturer reference (b)(4).Following a pvc ablation procedure, a pericardial effusion occurred.Transseptal puncture was performed and the safire blu ablation catheter was advanced through a sl0 introducer and ablation was successfully completed in the left ventricle.After the devices were removed, the patient became nauseated and bradycardic.Anti-nausea and blood pressure medications were administered and an echocardiogram revealed a small effusion; however, a pericardiocentesis was not required at that time.A pericardiocentesis was performed later and the patient recovered with no further issues.There were no performances issues with any sjm device.

• Brand Name: SAFIRE¿ BLU¿ ABLATION CATHETER
• Type of Device: IRRIGATED ABLATION CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(AF-IRVINE); 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4998203
• MDR Text Key: 22819892
• Report Number: 2030404-2015-00061
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/13/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• 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 SWARTZ SL0 INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 77