MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SUPREME? ELECTROPHYSIOLOGY CATHETER, HEXAPOLAR (UNIPOLAR RECORDING), 120 CM LENG; DIAGNOSTIC EP CATHETER

Model Number 401877

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

Patient Problems High Blood Pressure/ Hypertension (1908); Pericardial Effusion (3271)

Event Date 10/07/2014

Event Type  Injury  

Event Description

During a premature ventricular contraction (pvc) ablation procedure using a supreme ep hexapolar catheter, a pericardial effusion occurred.A non-sjm quadripolar catheter was placed in the coronary sinus and a supreme hexapolar ep catheter was placed in the his position.A non-sjm ice catheter was placed in the right atrium and a small pericardial effusion was noted.The physician believed it could be chronic in nature but was not sure.A non-sjm catheter was then placed in the left ventricle via retrograde approach and, as mapping continued, the patient became hypertensive.It was noted the pericardial effusion had increased in size; therefore, the procedure was aborted and a pericardiocentesis was performed.The patient was transferred out of the ep lab and further imaging revealed no evidence of perforation.The cause of the pericardial effusion remains unknown.

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, cardiac perforation is a known risk during the use of this device.

• Brand Name: SUPREME? ELECTROPHYSIOLOGY CATHETER, HEXAPOLAR (UNIPOLAR RECORDING), 120 CM LENG
• Type of Device: DIAGNOSTIC EP CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4226552
• MDR Text Key: 21084415
• Report Number: 3005188751-2014-00134
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK002976
• 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
• Report Date: 10/07/2014

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: 07/31/2017
• Device Model Number: 401877
• Device Lot Number: 4724662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• 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: UNKNOWN BARD DECAPOLAR CATHETER; UNKNOWN BIOSENSE WEBSTER CATHETER
• Patient Outcome(s): Required Intervention
• Patient Weight: 70