MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY? COOL FLEX? ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A088015

Device Problems High impedance (1291); Device Displays Incorrect Message (2591)

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

Event Date 11/17/2014

Event Type  Injury  

Event Description

During an atrial fibrillation ablation procedure using a therapy cool flex ablation catheter, a pericardial effusion occurred.The therapy cool flex ablation catheter was used in the left atrium with a fast-cath swartz transseptal introducer.After ablating for approximately 2 hours, an impedance rise was observed along with an impedance error on the generator.The patient became hypotensive and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any sjm device.

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 and may be procedure related.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• Brand Name: THERAPY? COOL FLEX? ABLATION CATHETER IRRIGATED 4 MM TIP THERMOCOUPLE QUADRIPOLA
• 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: 4281526
• MDR Text Key: 5033973
• Report Number: 2030404-2014-00101
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PP110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: A088015
• Device Lot Number: 4477499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2014
• 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 SWARTZ TRANSSEPTAL INTRODUCER 406849; BRK NEEDLE 407200; AFOCUS II CATHETER 87008; STOCKERT GENERATOR; BIOSENSE WEBSTER SAFE SEPTAL; INQUIRY CATHETER 81104
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 68