BRK? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH G407208

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 2020-03-11 for BRK? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH G407208 manufactured by St. Jude Medical, Costa Rica Ltda.

Event Text Entries

[183006001] 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 pericardial effusion 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


[183006002] Related manufacturing reference: 3005334138-2020-00097, 3005334138-2020-00098, 3008452825-2020-00139. During a redo pulmonary vein isolation procedure a pericardial effusion occurred. Following a difficult transseptal puncture, once transseptal access was obtained echocardiography was performed revealing a small pericardial effusion. It was decided to not continue with the ablation procedure and the patient was monitored. The patient recovered with no intervention needed. There were no performance issues with any abbott device. The perforation was located in front of the posterior and lateral walls of the left ventricle and right chambers.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008452825-2020-00138
MDR Report Key9817778
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2020-02-21
Date Mfgr Received2020-02-21
Device Manufacturer Date2019-11-22
Date Added to Maude2020-03-11
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, 71 CM LENGTH
Generic NameTROCAR
Product CodeDRC
Date Received2020-03-11
Model NumberG407208
Catalog NumberG407208
Lot Number7286577
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. Other 2020-03-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.