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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS DEVICE, BIOPSY, ENDOMYOCARDIAL

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ST. JUDE MEDICAL PROCURE ENDOMYOCARDIAL BIOPSY FORCEPS DEVICE, BIOPSY, ENDOMYOCARDIAL Back to Search Results
Model Number 408296
Device Problem Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2020
Event Type  malfunction  
Event Description
During a myocardial biopsy the endomyocardial biopsy forceps failed to open on the third biopsy. Fda safety report id# (b)(4).
 
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Brand NamePROCURE ENDOMYOCARDIAL BIOPSY FORCEPS
Type of DeviceDEVICE, BIOPSY, ENDOMYOCARDIAL
Manufacturer (Section D)
ST. JUDE MEDICAL
plymouth MN 55442
MDR Report Key10448256
MDR Text Key204421965
Report NumberMW5096230
Device Sequence Number1
Product Code DWZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number408296
Device Catalogue Number408296
Device Lot Number9917304
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/24/2020 Patient Sequence Number: 1
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