MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY¿ DUAL-8¿ ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number IBI-83372

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/20/2015

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 effusion could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

Event Description

Related manufacturing reference: 3005188751-2015-00130, 3005334138-2015-00111, and 3008452825-2015-00121.During a wpw procedure, a cardiac perforation occurred.During a post procedure intracardiac echo, a cardiac effusion was noted.The patient became hypotensive and a pericardiocentesis was performed which stabilized the patient.There were no performance issues with any sjm devices.

• Brand Name: THERAPY¿ DUAL-8¿ ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 5302445
• MDR Text Key: 33642990
• Report Number: 2030404-2015-00086
• 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
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IBI-83372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2015
• 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: BRK TRANSSEPTAL NEEDLE
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 95