MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER, 7F; CATHETER, PERCUTANEOUS CARDIAC ABLATION

Model Number IBI-88008

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

Patient Problem Cardiac Perforation (2513)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

Gtin: (b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

Event Description

Related manufacturing reference: 2182269-2015-00022.A pericardial effusion occurred post roof line ablation.The therapy cool path duo ablation catheter was used with the artisan sheath.The artisan sheath was re-calibrated and re-aligned several times due to movement issues with the device.The patient became hypotensive and fluoroscopy revealed a light shadow surrounding the heart shadow.An echocardiogram was performed which confirmed an effusion.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any sjm devices.

• Brand Name: THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER, 7F
• 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: 5101767
• MDR Text Key: 26715920
• Report Number: 2030404-2015-00067
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/25/2015

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 Expiration Date: 09/30/2017
• Device Model Number: IBI-88008
• Device Lot Number: 4823331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 65