MAUDE Adverse Event Report: ST. JUDE MEDICAL (AF MINNETONKA) TRANSSEPTAL NEEDLE, BRK 1, 71CM

Model Number 407201

Device Problems Entrapment of Device (1212); Fracture (1260); Positioning Problem (3009)

Patient Problem Pericardial Effusion (3271)

Event Date 12/18/2013

Event Type  Injury  

Event Description

During an atrial fibrillation ablation procedure using a brk transseptal needle, a pericardial effusion occurred.Two transseptal punctures were performed with the brk transseptal needle and a fast cath swartz transseptal introducer.A non-sjm lasso catheter was advanced into the left atrium, fractured, and became entangled in the mitral valve.The pt developed a pericardial effusion.A pericardiocentesis was performed, which stabilized the pt.The physician does not believe the performance of any sjm device was contributory to the lasso entrapment and subsequent fracture.The physician also believes the pericardial effusion stemmed from the initial transseptal puncture, which may have been attempted too posteriorly.

Manufacturer Narrative

The results of the investigations are inconclusive since the device was not returned or analysis.Our analysis 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 info received, the cause of the reported pericardial effusion was procedure related.Per the ifu, cardiac perforation is a known inherent risk during the use of this device in the heart.

• Brand Name: TRANSSEPTAL NEEDLE, BRK 1, 71CM
• Manufacturer (Section D): ST. JUDE MEDICAL (AF MINNETONKA); minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 177 east county rd b; st. paul, MN 55117 ; 6517564071
• MDR Report Key: 3565201
• MDR Text Key: 19971070
• Report Number: 3005188751-2013-00135
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• 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: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 407201
• Device Lot Number: 3790414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: (406849/4037899); FAST CATH SWARTZ TRANSSEPTAL INTRODUCER; THERAPY COOL PATH CATHETER (84308/4075619); (D7-L10-15-RT/LOT NUMBER UNK); BIOSENSE WEBSTER LASSO CATHETER; COOL POINT PUMP (85785/SN (B)(4)); ENSITE VELOCITY MAPPING SYSTEM; (406849/4037899); FAST CATH SWARTZ (TRANSSEPTAL INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 100