BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH 407200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-17 for BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH 407200 manufactured by St. Jude Medical.

Event Text Entries

[183906831] An event of a pericardial effusion was reported. 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


[183906832] Related manufacturing ref: 2030404-2020-00020, 3005334138-2020-00112. During a typical atrial flutter ablation procedure, a pericardial effusion occurred. Transseptal puncture was attempted but appeared too high and posterior, so a second puncture was conducted. A non-abbott catheter was then inserted but the patient became hypotensive. Anesthesia was administered and ice revealed a pericardial effusion in the left atrium. A pericardiocentesis was performed but the patient required surgery. The patient is in stable condition. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008452825-2020-00147
MDR Report Key9841531
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2020-02-26
Date Mfgr Received2020-02-26
Device Manufacturer Date2019-12-11
Date Added to Maude2020-03-17
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
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? TRANSSEPTAL NEEDLE, 71 CM LENGTH
Generic NameTROCAR
Product CodeDRC
Date Received2020-03-17
Model Number407200
Catalog Number407200
Lot Number7309361
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
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 2020-03-17

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