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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL PUERTO RICO, INC. FEMOSTOP¿ GOLD FEMOSTOP GOLD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pseudoaneurysm (2605)
Event Date 12/07/2017
Event Type  Injury  
Manufacturer Narrative
An event of "deployment was not completed and no seal was created" and a "hematoma" and a "false aneurysm" 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 arterio-venous fistula or pseudoaneurysm is a possible complication from the use of this device. The femostop gold ifu states to minimize the risk for arterial/venous fistula formation, venous hemostasis should be achieved prior to removal of the arterial sheath. 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. The femostop gold ifu states that adequate compression may not be obtained in markedly obese patients.
 
Event Description
Post procedure, the interventional radiologist went to deploy a non-abbott device, but the deployment was not completed and no seal was created. The radiologist used a femostop gold and then manual compression. However, the patient developed a hematoma. Contact with the nurses the following day indicated that the patient has a false aneurysm at the site and remains in hospital.
 
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Brand NameFEMOSTOP¿ GOLD
Type of DeviceFEMOSTOP GOLD
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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key7169028
MDR Text Key176338078
Report Number2648612-2018-00002
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K110193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2017
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/05/2018 Patient Sequence Number: 1
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