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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. EMBOSPHERES MICROSPHERES; AGENTS, EMBOLIC FOR TREATMENT OF BENIGN PROSTATE HYPERPLASIA
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MERIT MEDICAL SYSTEMS, INC. EMBOSPHERES MICROSPHERES; AGENTS, EMBOLIC FOR TREATMENT OF BENIGN PROSTATE HYPERPLASIA Back to Search Results
Model Number S420GH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Thrombosis (2100); Lethargy (2560)
Event Date 06/13/2019
Event Type  Injury  
Event Description
Subject reported to clinic for scheduled research visit.Complained of abdominal pain, lethargy.Had stopped taking lasix and aldactone for "several days" before.Was tachycardic, (hr 118) with decreased na, potassium and increased total bilirubin.Patient admitted to hospital via ed.Ct abdomen showed portal vein and superior mesenteric vein thrombosis.Put on anticoagulants (heparin).Underwent thrombolysis on (b)(6) 2019.On ct abd pelvis from (b)(6) 2019, "unchanged portal and superior mesenteric venous thrombosis''.Remains admitted at time of report.
 
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Brand Name
EMBOSPHERES MICROSPHERES
Type of Device
AGENTS, EMBOLIC FOR TREATMENT OF BENIGN PROSTATE HYPERPLASIA
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
MDR Report Key8785827
MDR Text Key151170539
Report NumberMW5088062
Device Sequence Number1
Product Code NOY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Model NumberS420GH
Device Catalogue NumberS420GH/A
Device Lot NumberX1168511-5
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age65 YR
Patient Weight95
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