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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 Pseudoaneurysm (2605)
Event Date 07/26/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Following a diagnostic coronary angiogram procedure, a pseudoaneurysm occurred. Manual arterial compression was applied for 20 minutes and a femostop was placed for 3 to 4 hours, with cessation of arteriotomy bleeding. Discoloration and mild to moderate hematoma was noted and a bedside ultrasound was performed which revealed a pseudoaneurysm with continuous intramural bleeding. Vascular surgery was notified and patient was taken to surgery for repair. General anesthesia was administered, irrigation and debridement were performed to relieve the pseudoaneurysm followed by surgical repair of the vessel and subcutaneous thrombin material injection. There was no adverse patient sequela after surgical repair and no reported clinically significant delay in the coronary angiographic procedure or therapy.
 
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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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8949261
MDR Text Key156093549
Report Number2648612-2019-00067
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,Followup
Report Date 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
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? No
Event Location No Information
Date Manufacturer Received09/03/2019
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: 08/30/2019 Patient Sequence Number: 1
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