Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; Trocar
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; Trocar Back to Search Results
Model Number G407208
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/03/2024
Event Type  malfunction  
Event Description
During the atrial fibrillation procedure, when removing the needle from the introducer, it was noted that the needle was fractured.The device was replaced and the procedure was completed with no adverse consequences to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
Type of Device
Trocar
Manufacturer (Section D)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS  1897-4050
Manufacturer (Section G)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS   1897-4050
Manufacturer Contact
janna parks
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key19116286
MDR Text Key340462994
Report Number3008452825-2024-00220
Device Sequence Number1
Product Code DRC
UDI-Device Identifier05414734205139
UDI-Public(01)05414734205139(10)10232544(17)270228
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG407208
Device Lot Number10232544
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/16/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-