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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. OPTION FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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ARGON MEDICAL DEVICES INC. OPTION FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Lot Number Q1429690
Device Problems Break (1069); Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/06/2020
Event Type  Malfunction  
Event Description

Ivc filter removal -1 barb broke off and remained extravascular. Fda safety report id# (b)(4).

 
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Brand NameOPTION FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
MDR Report Key10430857
MDR Text Key203823135
Report NumberMW5096143
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberQ1429690
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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