BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER

    MDR report key: 9215486 · Received October 21, 2019

    Report

    Report Number
    2020394-2019-04175
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Report Date
    April 20, 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 PROVIDED FOR ALL SIX MALFUNCTIONS AND THE LOT HISTORY REVIEW WERE PERFORMED. THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED AND REVIEWED FOR ALL SIX MALFUNCTIONS AND IMAGE WAS PROVIDED FOR ONE MALFUNCTION. THEREFORE, FOR THREE MALFUNCTIONS, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FILTER TILT AND DIFFICULT TO REMOVE. FOR ONE MALFUNCTION, THE INVESTIGATION IS CONFIRMED FOR DIFFICULT TO REMOVE AND INCONCLUSIVE FOR FILTER TILT, FOR ANOTHER ONE MALFUNCTION, INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT AND DIFFICULT TO REMOVE AND IT WAS DETERMINED TO HAVE AND CONFIRMED FOR PERFORATION(A0101) AND FOR THE REMAINING ONE MALFUNCTION INVESTIGATION IS CONFIRMED FOR FILTER TILT AND DIFFICULT TO REMOVE AND IT WAS DETERMINED TO HAVE AND CONFIRMED FOR PERFORATION(A0101), DETACHMENT(A0501) AND PARTIAL OCCLUSION(A140902). BASED ON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICES ARE 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.

    Additional Manufacturer Narrative · 0

    H10. OF THE 6 DEVICES, 6 LOT NUMBERS WERE PROVIDED, AND LOT HISTORY REVIEWS WERE PERFORMED. OF THE 6 REPORTED MALFUNCTIONS, NO DEVICES WERE RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED FOR 5 DEVICES, IMAGES WERE PROVIDED FOR ONE DEVICE AND REVIEWED FOR EACH MALFUNCTION. FILTER TILT AND RETRIEVAL DIFFICULTIES WERE CONFIRMED FOR 3 DEVICES. FOR ONE DEVICE, THE INVESTIGATION IS CONFIRMED FOR ALLEGED RETRIEVAL DIFFICULTIES. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR ALLEGED FILTER TILT. FOR REMAINING TWO DEVICES, THE INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT AND RETRIEVAL DIFFICULTIES. A ROOT CAUSE HAS NOT BEEN DETERMINED. THE DEVICES WERE LABELED FOR SINGLE USE. H10: D4 (CORPORATE LOT NO: GFVF4244, GFWI3161, GFUI2733), G4. H11: B5, G1. 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 SIX MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EC500F VENA CAVA FILTER ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE AND MALPOSITION OF DEVICE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL SIX MALFUNCTIONS INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. OF THE SIX PATIENTS, FIVE WERE FEMALE AND ONE WAS MALE, ALL SIX PATIENTS AGE RANGED FROM 26 - 67 YEARS AND FOUR PATIENTS WEIGHT WERE RANGED FROM 130 - 282 POUNDS. REMAINING TWO PATIENTS WEIGHT WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES SIX MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EC500F VENA CAVA FILTER ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE AND MALPOSITION OF DEVICE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL SIX MALFUNCTIONS INVOLVED A PATIENT WITH NO REPORTED PATIENT CONSEQUENCES. OF THE SIX REPORTED PATIENTS, FOUR PATIENTS RANGED FROM 45 ¿ 52 YEARS OF AGE, THREE PATIENT WEIGHT RANGED FROM 130¿ 282 POUNDS, AND ONE PATIENT WAS 104 KGS. OF THE SIX REPORTED PATIENTS, FIVE WERE FEMALE AND ONE WAS MALE; HOWEVER, OTHER PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    OF THE 6 DEVICES, 6 LOT NUMBERS WERE PROVIDED, AND LOT HISTORY REVIEWS WERE PERFORMED. OF THE 6 REPORTED MALFUNCTIONS, NO DEVICES WERE RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED FOR 4 DEVICES AND REVIEWED FOR EACH MALFUNCTION. FILTER TILT AND RETRIEVAL DIFFICULTIES WERE CONFIRMED FOR 3 DEVICES AND 1 WAS INCONCLUSIVE. 2 DEVICES SAMPLES OR MEDICAL RECORDS WERE NOT PROVIDED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE. A ROOT CAUSE HAS NOT BEEN DETERMINED. THE DEVICES WERE LABELED FOR SINGLE USE. CORPORATE LOT NO (GFVF4244, GFWI3161, GFUI2733).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES SIX MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL EC500F. VENA CAVA FILTER ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE AND MALPOSITION OF DEVICE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. ALL SIX EVENTS INVOLVED A PATIENT WITH NO REPORTED PATIENT CONSEQUENCES. OF THE SIX REPORTED PATIENT, THREE PATIENTS RANGED FROM 45 ¿ 52 YEARS OF AGE, THREE PATIENT WEIGHT RANGED FROM 130¿ 282 LBS. OF THE SIX REPORTED PATIENTS, FOUR WERE FEMALE AND ONE WAS MALE; HOWEVER, OTHER PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010244 ECLIPSE FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFWD3705, GFWA0402, GFVJ0754

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown