BRK-1? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH G407209

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-10 for BRK-1? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH G407209 manufactured by St. Jude Medical, Costa Rica Ltda.

Event Text Entries

[178506614] The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was not reviewed as the batch number was not available. Based on the information received, the cause of the reported incident could not be conclusively determined. Per the ifu, cardiac perforation is a known risk during the use of this device.
Patient Sequence No: 1, Text Type: N, H10


[178506615] During an amplatzer amulet implant procedure a pericardial effusion occurred. During the first transseptal attempted the patient developed a pericardial effusion. A pericardiocentesis was performed and the patient was stabilized to continue the procedure. The second transseptal was successful and the amulet was deployed and implanted, however; the effusion was drained multiple times. Following the procedure the patient was transferred to the intensive care unit for monitoring.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008452825-2020-00075
MDR Report Key9690089
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-10
Date of Report2020-02-18
Date of Event2020-01-23
Date Mfgr Received2020-02-12
Date Added to Maude2020-02-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL, COSTA RICA LTDA
Manufacturer StreetPARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL
Manufacturer CityALAJUELA, COSTA RICA 1897-4050
Manufacturer CountryCS
Manufacturer Postal Code1897-4050
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBRK-1? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
Generic NameTROCAR
Product CodeDRC
Date Received2020-02-10
Model NumberG407209
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, COSTA RICA LTDA
Manufacturer AddressPARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 1897-4050 CS 1897-4050


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Required No Informationntervention 2020-02-10

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