BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP RETRIEVAL BASKET

    MDR report key: 802828 · Received January 9, 2007

    Report

    Report Number
    6000048-2007-00016
    Event Type
    Injury
    Date Received
    January 9, 2007
    Date of Event
    December 21, 2006
    Report Date
    December 22, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KTI
    PMA / PMN Number
    k0202765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY THE MFR, BUT AN EVAL HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING A THERAPEUTIC STONE RETRIEVAL USING A ZERO TIP RETRIEVAL BASKET (PT GENDER AND AGE UNK), THE BASKET DETACHED FROM THE DEVICE. THE PHYSICIAN RETRIEVED THE BASKET USING A GRAPER. THE PT'S CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP RETRIEVAL BASKET KTI KTI BOSTON SCIENTIFIC M0063901050 923160

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention