BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 11226836 · Received January 25, 2021

    Report

    Report Number
    2020394-2021-80126
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER WAS PROVIDED FOR 20 OUT OF 26 MALFUNCTIONS, THEREFORE, LOT HISTORY REVIEWS WERE PERFORMED. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR ALL THE TWENTY SIX MALFUNCTIONS. IMAGES WERE PROVIDED AND REVIEWED FOR 4 MALFUNCTIONS. OUT OF 26 MALFUNCTIONS, 19 MALFUNCTIONS WERE CONFIRMED FOR THE ALLEGED FILTER TILT AND PERFORATION. FOUR MALFUNCTIONS WERE CONFIRMED FOR FILTER PERFORATION BUT INCONCLUSIVE FOR TILT. TWO MALFUNCTIONS ARE INCONCLUSIVE ARE FILTER TILT AND PERFORATION AS THERE IS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED. THE REMAINING MALFUNCTION IS CONFIRMED FOR ALLEGED FILTER PERFORATION BUT UNCONFIRMED FOR TILT.BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN.THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4(CORPORATE LOT NO: GFRE4510, GFQK3520, GFQJ4637, GFSA3522, GFVC0369, GFRC0558, GFRD1159, GFRE4527, GFSH2176, GFTB3637, GFQB2946, GFQJ4679, GFUB1420, GFTB3642, GFPH1441, GFTE3410, GFUB1416, UNKNOWN). 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 26 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED TILT AND PERFORATION. THESE INFORMATION'S WERE RECEIVED FROM A VARIOUS SOURCES. ALL 26 MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE 26 PATIENTS, SEVENTEEN WERE MALE AND EIGHT WERE FEMALE, 23 PATIENTS AGES RANGED FROM 28-81 YEARS AND 5 PATIENTS WEIGHS IN THE RANGE BETWEEN 210-339 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    OF THE REPORTED 26 MALFUNCTIONS, LOT NUMBER WERE PROVIDED FOR TWENTY MALFUNCTIONS AND THE LOT HISTORY REVIEW WERE PERFORMED. THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION; HOWEVER; MEDICAL RECORDS WERE RECEIVED FOR ALL 26 MALFUNCTIONS AND IMAGE WAS PROVIDED FOR ONE MALFUNCTION. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED TILT AND PERFORATION FOR EIGHTEEN MALFUNCTIONS, THE INVESTIGATION INCONCLUSIVE FOR THE REPORTED TILT AND PERFORATION FOR TWO MALFUNCTIONS, FOR THREE MALFUNCTIONS THE INVESTIGATION IS CONFIRMED FOR PERFORATION AND INCONCLUSIVE FOR TILT AND FOR ONE MALFUNCTION THE INVESTIGATION IS CONFIRMED FOR PERFORATION AND UNCONFIRMED FOR TILT. FOR THE REMAINING TWO MALFUNCTIONS THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICES ARE LABELED FOR SINGLE USE. (CORPORATE LOT NO: GFRE4510, GFQK3520, GFQJ4637, GFSA3522, GFVC0369, GFRC0558, GFRD1159, GFRE4527, GFSH2176, GFTB3637, GFQB2946, GFQJ4679, GFUB1420, GFTB3642, GFPH1441, GFTE3410, GFUB1416, UNKNOWN).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 26 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL RF310F VENA CAVA FILTER ALLEGEDLY EXPERIENCED TILT AND PERFORATION. THESE INFORMATION'S WERE RECEIVED FROM A VARIOUS SOURCES. ALL 26 MALFUNCTIONS INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. OF THE 26 PATIENTS, SEVENTEEN WERE MALE AND EIGHT WERE FEMALE, 23 PATIENTS AGE RANGED FROM 28-81 YEARS AND FIVE PATIENT WEIGHS IN THE RANGE BETWEEN 210-339 LBS. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121605 G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFPH2835, GFTB3651, GFSL1256

    Patients

    Seq Age Sex Outcome Treatment
    1