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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FEMOSTOP GOLD FEMORAL COMPRESSION SYSTEM; CLAMP, VASCULAR
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ST. JUDE MEDICAL, INC. FEMOSTOP GOLD FEMORAL COMPRESSION SYSTEM; CLAMP, VASCULAR Back to Search Results
Model Number C11165
Device Problem Infusion or Flow Problem (2964)
Patient Problems Numbness (2415); Diminished Pulse Pressure (2606); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/30/2021
Event Type  malfunction  
Event Description
Patient was picked up in cath lab with fem stop in place on right groin.When arrived to icu, patient's right leg was cold, mottled, had numbness/tingling, and without pedal/pt pulses.Air was unable to be let out of device r/t device malfunction or user error when applied.Cardiovascular monitor tech and consultant at bedside to remove fem stop device.Patient without pedal pulses for 10 minutes.Doppler post tib.Pulses achieved 10 minutes, pedal pulses dopplerable within 2 hours, both pulses then palpable 12 hours after incident.
 
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Brand Name
FEMOSTOP GOLD FEMORAL COMPRESSION SYSTEM
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
5050 nathan lane north
plymouth MN 55442
MDR Report Key12060230
MDR Text Key258148965
Report Number12060230
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 Other Health Care Professional
Type of Report Initial
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberC11165
Device Catalogue NumberC11165
Device Lot Number7655193
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2021
Event Location Other
Date Report to Manufacturer06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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