BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY FILTER

    MDR report key: 9972954 · Received April 17, 2020

    Report

    Report Number
    2020394-2020-02939
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Report Date
    July 23, 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: THE LOT NUMBERS WERE NOT PROVIDED AND A LOT HISTORY REVIEWS COULD NOT BE PERFORMED. THE DEVICES WERE NOT RETURNED FOR EVALUATION; THEREFORE THE INVESTIGATION IS INCONCLUSIVE FOR ALL THE ALLEGED MALFUNCTIONS. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICES ARE LABELED FOR SINGLE USE. SANJEEVA P KALVA, CHRISTOS A ATHANASOULIS, CHIEH-MIN FAN, MARCIO CURVELO, STUART C GELLER, ALAN J GREENFIELD, ET AL (2006). ¿RECOVERY¿ VENA CAVA FILTER: EXPERIENCE IN 96 PATIENTS. CARDIOVASC INTERVENT RADIOL, 29(4):559¿564. DOI: 10.1007/S00270-005-0271-1. 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 WAS NOT PROVIDED AND A LOT HISTORY REVIEW COULD NOT BE PERFORMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED MALFUNCTION. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE IS LABELED FOR SINGLE USE. 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.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 30 MALFUNCTIONS. THE INFORMATION REVIEWED INDICATED THAT MODEL RF048F VENA CAVA FILTER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT, ACTIVATION FAILURE INCLUDING EXPANSION FAILURE, AND PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ALL 30 PATIENTS WITH NO PATIENTS¿ CONSEQUENCES. THE AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 30 MALFUNCTIONS. THE INFORMATION REVIEWED INDICATED THAT MODEL RF048F VENA CAVA FILTER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT (4), ACTIVATION FAILURE INCLUDING EXPANSION FAILURE (12), AND PATIENT-DEVICE INCOMPATIBILITY (14). THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ALL 30 PATIENTS WITH NO PATIENTS¿ CONSEQUENCES. THE AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED AND A LOT HISTORY REVIEW COULD NOT BE PERFORMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE THE INVESTIGATION IS INCONCLUSIVE FOR DETACHMENT OF DEVICE OR DEVICE COMPONENT, ACTIVATION FAILURE INCLUDING EXPANSION FAILURE, AND PATIENT-DEVICE INCOMPATIBILITY. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE IS LABELED FOR SINGLE USE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 30 MALFUNCTIONS. THE INFORMATION REVIEWED INDICATED THAT MODEL RF048F VENA CAVA FILTER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT (4), ACTIVATION FAILURE INCLUDING EXPANSION FAILURE (12), AND PATIENT-DEVICE INCOMPATIBILITY (14). THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ALL 30 PATIENTS WITH NO PATIENTS¿ CONSEQUENCES. THE AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438048 RECOVERY FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown