BRK? XS TRANSSEPTAL NEEDLE, 98 CM LENGTH G407211

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 2020-01-31 for BRK? XS TRANSSEPTAL NEEDLE, 98 CM LENGTH G407211 manufactured by St. Jude Medical, Costa Rica Ltda.

Event Text Entries

[177193894] 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 effusion remains unknown. Per the ifu, cardiac perforation is a known risk during the use of this device.
Patient Sequence No: 1, Text Type: N, H10


[177193895] During transseptal puncture, a pericardial effusion occurred. Contrast medium was used to assist during transseptal and it was noted that the needle was on the septum with tenting, but introduction of the guidewire revealed that it was not in the left atrium. The patient began to feel unwell a few seconds after puncture and was treated with medication before a second successful puncture. After a worsening of the patient's hemodynamic state, an ultrasound revealed a pericardial effusion for which a pericardiocentesis was performed to stabilize the patient. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008452825-2020-00064
MDR Report Key9652799
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-31
Date of Report2020-01-31
Date of Event2020-01-20
Date Mfgr Received2020-01-20
Device Manufacturer Date2019-10-11
Date Added to Maude2020-01-31
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? XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
Generic NameTROCAR
Product CodeDRC
Date Received2020-01-31
Model NumberG407211
Catalog NumberG407211
Lot Number7222205
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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. Required No Informationntervention 2020-01-31

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