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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. G2 IVC FILTER FILTER INTRAVASCULAR, CARDIOVASCULAR

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BARD PERIPHERAL VASCULAR INC. G2 IVC FILTER FILTER INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Device Problems Fracture (1260); Tip (3123)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/30/2019
Event Type  Injury  
Event Description

G2 ivcf found to have migrated significantly and fractured, tip embedded with half of one leg extravascular in diaphragmatic crus. Filter removed with forceps, fragment not removed as is extravascular. Fda safety report id# (b)(4).

 
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Brand NameG2 IVC FILTER
Type of DeviceFILTER INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC.
tempe AZ
MDR Report Key8671484
MDR Text Key147243127
Report NumberMW5087136
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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

Patient TREATMENT DATA
Date Received: 06/04/2019 Patient Sequence Number: 1
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