MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) BRK? XS TRANSSEPTAL NEEDLE, 98 CM LENGTH

Model Number G407211

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 08/12/2014

Event Type  Injury  

Event Description

Related manufacturer reference 3005188751-2014-00102, 2030404-2014-00086, 3008452825-2014-00033 during a ventricular tachycardia ablation procedure, a pericardial effusion occurred.Transseptal puncture was performed with a brk transseptal needle and an agilis nxt introducer was advanced across the septum into the left atrium.An inquiry quadripolar ep catheter was placed in the right ventricle for mapping purposes.A therapy cool path ablation catheter was advanced into the left ventricle and ablation was performed.After ablation, the patient became hypotensive and complained of mild chest pain.An echocardiogram revealed a pericardial effusion; however, no pericardiocentesis was required as the effusion remained stable and the patient exhibited no further symptoms.There were no performance issues with any sjm device.

Manufacturer Narrative

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: BRK? XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4063586
• MDR Text Key: 4854823
• Report Number: 3005188751-2014-00101
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK072278
• 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: 08/12/2014

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: Other
• Device Expiration Date: 12/21/2016
• Device Model Number: G407211
• Device Catalogue Number: G407211
• Device Lot Number: 4418207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• 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: AGILIS NXT INTRODUCER; INQUIRY QUADRIPOLAR EP CATHETER; THERAPY COOL PATH ABLATION CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 101