BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER

    MDR report key: 9968662 · Received April 16, 2020

    Report

    Report Number
    2020394-2020-02875
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Report Date
    July 21, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICES WERE NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. LUIS F. ANGEL, VICTOR TAPSON, RICHARD E. GALGON, MARCOS I. RESTREPO, AND JOHN KAUFMAN (2011). SYSTEMATIC REVIEW OF THE USE OF RETRIEVABLE INFERIOR VENA CAVA FILTERS. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 22(11):1522-1530.E3. DOI: 10.1016/J.JVIR.2011.08.024. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE MALFUNCTION IS UNKNOWN, THEREFORE THE MANUFACTURING REVIEW COULD NOT BE CONDUCTED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 576 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL UNKNOWN G2 VENA CAVA ALLEGEDLY EXPERIENCED MIGRATION, DIFFICULTY TO REMOVE, MALPOSITION OF DEVICE, DETACHMENT OF DEVICE, DEPLOYMENT ISSUE AND PATIENT-DEVICE INTERACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL UNKNOWN G2 VENA CAVA ALLEGEDLY EXPERIENCED MIGRATION, DIFFICULTY TO REMOVE, MALPOSITION OF DEVICE, DETACHMENT OF DEVICE, AND PATIENT-DEVICE INTERACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE MALFUNCTION IS UNKNOWN, THEREFORE THE MANUFACTURING REVIEW COULD NOT BE CONDUCTED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR MIGRATION, DIFFICULTY TO REMOVE, MALPOSITION OF DEVICE, DETACHMENT OF DEVICE, AND PATIENT-DEVICE INTERACTION PROBLEM AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. (DEVICE: (B)(4)).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL UNKNOWN G2 VENA CAVA ALLEGEDLY EXPERIENCED MIGRATION, DIFFICULTY TO REMOVE, MALPOSITION OF DEVICE, DETACHMENT OF DEVICE, AND PATIENT-DEVICE INTERACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433835 G2 FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown