MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ BLU¿ DUO ABLATION CATHETER IRRIGATED BI-DIRECTIONAL 4 MM TIP THERMOCOUPL; CATHETER, PERCUTANEOUS CARDIAC ABLATION

Model Number A088107

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 12/29/2014

Event Type  Injury  

Event Description

During a pulmonary vein isolation procedure using a safire blu duo ablation catheter, a pericardial effusion occurred.A transseptal puncture was performed with a non-sjm transseptal needle and a fast cath swartz transseptal introducer was advanced into the left atrium.A reflexion spiral ep catheter was then placed in the left atrium.A second transseptal puncture was performed with the non-sjm transseptal needle and an unsuccessful attempt to advance an agilis nxt introducer was made.The agilis nxt introducer was then replaced with a fast cath hemostasis introducer, through which a safire blu duo ablation catheter was placed.During manipulation of the catheter, the patient became hypotensive and a non-sjm ice catheter revealed a pericardial effusion, which was confirmed by an echocardiogram.Iv fluids were administered and a pericardiocentesis was performed, which stabilized the patient.The patient is currently doing well.There were no performance issues with the safire blu duo ablation catheter.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).One 7f, 4mm, medium curl, bi-directional, safire blu duo irrigated ablation catheter was received for evaluation.Bends in the shaft were noted just proximal to electrode ring 4 and at 4.90¿ proximal to the distal tip.The catheter deflected in both directions, but no longer deflected into the correct shape and no longer met specifications in one direction, due to bends in the shaft.The cause of the bends in the shaft is consistent with damage during use.Electrical testing revealed no anomalies.The device met specifications prior to release from sjm manufacturing facilities as supported by a review of the device history record.The cause of the reported pericardial effusion was unable to be confirmed and remains unknown.Per the ifu, vascular perforation in an inherent risk of any electrode placement.

• Brand Name: SAFIRE¿ BLU¿ DUO ABLATION CATHETER IRRIGATED BI-DIRECTIONAL 4 MM TIP THERMOCOUPL
• 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: 4457872
• MDR Text Key: 5427021
• Report Number: 2030404-2015-00005
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: A088107
• Device Catalogue Number: A088107
• Device Lot Number: 4836184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• 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: FAST CATH HEMOSTASIS INTRODUCER; FAST CATH SWARTZ TRANSSEPTAL INTRODUCER; REFLEXION SPIRAL EP CATHETER; SUPREME QUADRIPOLAR EP CATHETER; AGILIS NXT INTRODUCER; BAYLIS MEDICAL TRANSSEPTAL NEEDLE; LIVEWIRE DECPOLAR EP CATHETER; BIOSENSE WEBSTER ICE CATHETER; MERIT MEDICAL HYDROPHILIC GUIDEWIRE; COOK WIRE GUIDE
• Patient Outcome(s): Required Intervention
• Patient Weight: 106