MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. COOL PATH DUO, MEDIGUIDE, 1304-CP2-8-25-MC-BD-ME; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A700242

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Perforation (2513)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

(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

During an atrial fibrillation ablation procedure, a pericardial effusion occurred.A therapy cool path duo ablation catheter was used along with ensite velocity to collect geometry and the catheter was noted to be in an unexpected position.Some difficulty with catheter manipulation was noted during geometry collection.The patient became hypotensive and an echocardiogram revealed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.The patient was transferred to ccu for observation and overnight the patient became hypotensive.An echocardiogram revealed no pericardial effusion; however, a pleural effusion was noted.A thoracentesis was performed, which stabilized the patient, and no further effusion was present on follow up echocardiogram.

• Brand Name: COOL PATH DUO, MEDIGUIDE, 1304-CP2-8-25-MC-BD-ME
• 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: 5056615
• MDR Text Key: 25016097
• Report Number: 2030404-2015-00066
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: A700242
• Device Lot Number: 5044033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• 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: MEDIGUIDE SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 57