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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL PUERTO RICO, INC. FEMOSTOP GOLD CLAMP, VASCULAR Back to Search Results
Model Number C11165
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemostasis (1895)
Event Date 07/06/2018
Event Type  Injury  
Manufacturer Narrative
An event of bleeding was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. The femostop gold instructions for use (ifu) states that bleeding or hematoma are possible complications from the use of the device. The femostop gold ifu states that if arterial/venous hemostasis is not achieved, significant bleeding may occur which could result in patient injury or death. The femostop gold ifu states for successful compression, the system must be snug and secure around the patient¿s hips before pressure is applied. Do not over-tighten the belt.
 
Event Description
The femostop was used to achieve hemostasis. In the icu, the patient moved their leg excessively and the device shifted. The patient developed a large hematoma and had to be taken to the operating room where a surgical cut down was performed under general anesthesia. Hemostasis was then achieved with surgical suturing. It is unclear if the proglide was initially responsible for the bleed; however, the hematoma was formed after removal of the femostop.
 
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Brand NameFEMOSTOP GOLD
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
ST. JUDE MEDICAL PUERTO RICO, INC.
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
Manufacturer (Section G)
ST. JUDE MEDICAL PUERTO RICO, INC.
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
Manufacturer Contact
elizabeth boltz
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key7723555
MDR Text Key115137031
Report Number2648612-2018-00058
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberC11165
Device Catalogue NumberC11165
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/26/2018 Patient Sequence Number: 1
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