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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FEMOSTOP GOLD CLAMP, VASCULAR

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ST. JUDE MEDICAL, INC. FEMOSTOP GOLD CLAMP, VASCULAR Back to Search Results
Model Number GOLD
Device Problem Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 10/11/2021
Event Type  malfunction  
Event Description
When utilizing the device, to discontinue femoral arterial line, staff noticed error reading e05 on the display and no numbers when device was inflated. A second package was opened with same issues. A third package was opened and worked properly. All packages had the same lot number.
 
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Brand NameFEMOSTOP GOLD
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
5050 nathan lane north
plymouth MN 55442
MDR Report Key12933003
MDR Text Key281738304
Report Number12933003
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberGOLD
Device Catalogue NumberC11165
Device Lot Number7907926
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/01/2021
Date Report to Manufacturer12/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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