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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AMPLATZER¿ TALISMAN¿; TRANSCATHETER SEPTAL OCCLUDER
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ST. JUDE MEDICAL, INC. AMPLATZER¿ TALISMAN¿; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Model Number 9-PFO-3025
Device Problems Material Too Rigid or Stiff (1544); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 02/03/2022
Event Type  malfunction  
Event Description
The device was prepped and loaded, when it was advanced it wouldn't release.It was pulled back and advanced again but seems a bit stiff on pull back (resisted a little) a second device was used (same lot number) and had the same issue.Both plugs seemed a bit deformed.Rep that was supporting during the case wondered if it was the deployment device and not the plug itself.Device will be returned to company for evaluation.
 
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Brand Name
AMPLATZER¿ TALISMAN¿
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
5050 nathan lane north
plymouth MN 55442
MDR Report Key13782209
MDR Text Key287255475
Report Number13782209
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/04/2022,02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9-PFO-3025
Device Catalogue Number9-PFO-3025
Device Lot Number8202243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2022
Event Location Hospital
Date Report to Manufacturer03/16/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age14965 DA
Patient SexFemale
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