BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERC. THROMBOLYTIC DEVICE KIT

    MDR report key: 2241175 · Received August 17, 2011

    Report

    Report Number
    2242445-2011-00109
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    LKF
    PMA / PMN Number
    K010056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE RADIOLOGY DEPARTMENT, THE CATHETER "UNRAVELED" WHILE THE CASE WAS IN PROGRESS. AS A RESULT, THE MD COULD NOT INSERT THE BASKET INTO THE TIME OF THE CATHETER. THE MD REPLACED THE UNIT WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PT DEATH OR INJURY. THE CASE WAS DELAYED FOR THE TIME IT TOOK TO REPLACE THE UNIT. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT OUTCOME IS LISTED AS "THERE WAS NO HARMFUL OUTCOME TO THE PT." ADD'L INFO RECEIVED ON (B)(4) 2011 STATED THAT "THEY REMOVED THE CATHETER FROM THE PT BY PULLING IT OUT. THEY INSERTED THE CATHETER INTO THE PT AND DID THE PROCEDURE PROPERLY. HOWEVER, THE UNIT STOPPED SUDDENLY TO OPERATE THEN MD FOUND OUT THE LINE OF THE CATHETER UNRAVELED. THIS MD IS SKILLFUL AT PTD DEVICE SO, HE COULD HANDLE THE INCIDENT PROMPTLY. LINE OF THE CATHETER UNRAVELED, NOT THE BASKET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERC. THROMBOLYTIC DEVICE KIT PTD PRODUCTS LKF ARROW INTERNATIONAL INC MF1049800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK