MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ VELOCITY¿ SYSTEM DISPOSABLE PRODUCT, ENSITE¿ ARRAY¿ CATHETER; ELECTRODE RECORDING CATHETER

Model Number EC1000

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

Patient Problem Cardiac Perforation (2513)

Event Date 10/16/2017

Event Type  Injury  

Event Description

Related manufacturing ref: 2182269-2017-00130, 3008452825-2017-00267, 3008452825-2017-00268.During a premature ventricular contraction (pvc) mapping study, a pericardial effusion occurred.The catheter was positioned in the right ventricular outflow tract (rvot) and connected to the mapping system.Attempts to validate the catheter were unsuccessful; therefore, the catheter was exchanged and the case continued.Upon completion of the case, the patient became hypotensive and the ice catheter revealed a pericardial effusion.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any abbott devices.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, the risk of vascular perforation exists with any intracardiac catheter.

• Brand Name: ENSITE¿ VELOCITY¿ SYSTEM DISPOSABLE PRODUCT, ENSITE¿ ARRAY¿ CATHETER
• Type of Device: ELECTRODE RECORDING 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: 7008725
• MDR Text Key: 91292205
• Report Number: 2182269-2017-00131
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121006
• 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,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EC1000
• Device Lot Number: 5663392
• Other Device ID Number: 05414734215664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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: AGILIS NXT INTRODUCER; ENSITE ARRAY CATHETER; FLEXABILITY ABLATION CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 80