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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) BRK TRANSSEPTAL NEEDLE

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ST. JUDE MEDICAL, INC. (AF-MINNETONKA) BRK TRANSSEPTAL NEEDLE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Cardiac Perforation (2513)
Event Date 06/09/2014
Event Type  Injury  
Event Description
During an electrophysiology procedure using a brk transseptal needle, a cardiac perforation occurred.A non-sjm catheter was advanced to the left atrium after a transseptal puncture with a brk transseptal needle and an unknown introducer.A cardiac perforation was noted via fluoroscopy and confirmed with an echocardiogram.A pericardiocentesis was performed and the patient was transferred to the operating room prior to removal of the catheter and introducer in case surgical intervention was required.Further information has been requested but is not yet available.
 
Event Description
During an atrial fibrillation ablation procedure using a brk transseptal needle, a cardiac perforation occurred.During transseptal puncture, the brk transseptal needle was inadvertently advanced into the aorta.The procedure was stopped and the patient was transferred to surgery to remove the needle.The needle was removed with no further intervention required and the patient recovered without issue.There were no performance issues with the needle.
 
Manufacturer Narrative
Additional information: the results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported cardiac perforation was procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.
 
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Brand Name
BRK TRANSSEPTAL NEEDLE
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 Key4042452
MDR Text Key4860299
Report Number3005188751-2014-00100
Device Sequence Number1
Product Code DRC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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