BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS THROMBOLYTI C DEVICE KIT: 7

    MDR report key: 2903459 · Received January 4, 2013

    Report

    Report Number
    2242445-2013-00002
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 9, 2012
    Report Date
    January 4, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE CATH LAB AFTER USE WHEN REMOVING THE TEROTOLA, THE BASKET CAME APART/SEPARATED FROM THE CATHETER. AS A RESULT, THE DOCTOR USED A SNARE TO SUCCESSFULLY REMOVE BOTH PIECES OF THE BASKET WITH NO HARM TO THE PATIENT. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO ADDITIONAL HARM TO THE PATIENT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4380 PERCUTANEOUS THROMBOLYTI C DEVICE KIT: 7 PTD PRODUCTS DXE ARROW INTL., INC. MF2079782

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention