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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemostasis (1895)
Event Date 01/02/2018
Event Type  Injury  
Manufacturer Narrative
The reported event of hematoma could not be confirmed. 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 also 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. The femostop gold instructions for use (ifu) warns not to leave artery completely blocked for more than 3 minutes to prevent limb ischemia. Check pedal pulse periodically to confirm whether or not flow remains in the vessels.
 
Event Description
Two different femostop devices were used to close an access site after a stent was implanted to treat stemi. During recovery, the patient developed a hematoma at the access site, roughly the size of the palm of his hand. The patient complained of discomfort and pain in the leg. The next day the patient was sent to surgery as the hematoma had grown to roughly the size of a volleyball. It was noted that the access site did not initially close. The access site was at the bifurcation. Please reference 2648612-2018-00007 for other femostop gold device.
 
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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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key7228447
MDR Text Key98582195
Report Number2648612-2018-00006
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 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2018
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 Received01/29/2018
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: 01/30/2018 Patient Sequence Number: 1
Treatment
FEMOSTOP GOLD
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