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 TRANSSEPTAL NEEDLE, BRK SERIES
  • 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 TRANSSEPTAL NEEDLE, BRK SERIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Perforation (2513)
Event Date 08/30/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event were requested but not received.
 
Event Description
During a ventricular tachycardia ablation procedure, a pericardial effusion occurred.During a difficult transeptal procedure, the patient had no symptoms and a pericardial effusion in the left atrium was diagnosed with ultrasound.A pericardiocentesis was performed to stabilize the patient.It was indicated the event was related to patient anatomy as it took 35-40 minutes to do the transseptal puncture.
 
Manufacturer Narrative
No product was returned for investigation. a review of the device history record was not possible since the batch number is unavailable.Based on the information provided to abbott, the reported pericardial effusion could not be confirmed.Per the ifu, cardiac perforation is a known risk during the use of this device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRANSSEPTAL NEEDLE, BRK SERIES
Type of Device
TRANSSEPTAL NEEDLE
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
MDR Report Key9144767
MDR Text Key160851534
Report Number3008452825-2019-00495
Device Sequence Number1
Product Code DRC
Combination Product (y/n)N
PMA/PMN Number
K072278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age84 YR
-
-