BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERC. THROMBOLYTIC DEVICE KIT

    MDR report key: 1309584 · Received February 6, 2009

    Report

    Report Number
    2242445-2009-00004
    Event Type
    Injury
    Date Received
    February 6, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 6, 2009
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERCUTANEOUS THROMBOLYTIC DEVICE (PTD) SET PTD BASKET BECAME SUDDENLY STUCK INSIDE ARTERIOVENOUS (AV) GRAFT. WHEN PTD BASKET BECAME STUCK, CLINICIAN ATTEMPTED TO INTERVENTIONALLY REMOVE IT UNDER FLUOROSCOPY, BUT BASKET COULD NOT BE REMOVED. AS A RESULT, PATIENT (PT.) NEEDED URGENT SURGICAL INTERVENTION, WHICH WAS SUCCESSFUL; PT. HAS RECOVERED. ACCORDING TO CLINICIAN, HE CAREFULLY VERIFIED ALL FUNCTIONS OF PTD PRODUCTS INCLUDING ROTATOR DRIVE UNIT, SHEATH, CATHETER & FRAGMENTATION BASKET BEFORE HE USED IT. EVERY PRODUCT WORKED FINE, SO HE INSERTED SHEATH & THEN CATHETER INTO AV GRAFT SITE, WHERE IT WAS PLACED IN PT.'S LEFT FOREARM TO REMOVE THROMBUS. HE ACTIVATED PTD DEVICE ONCE & ACTIVATION TIME WAS LESS THAN 10 SECONDS. AFTER THAT, HE TRIED TO MOVE PTD BASKET INTO THE COMPRESSED POSITION, BUT BASKET WOULD NOT MOVE AT ALL & SUCKED INSIDE AV GRAFT. HE STATED HE FELT VERY STRONG RESISTANCE. HE DID MANY WAYS WHICH MIGHT BE HELPFUL FOR REMOVAL, SUCH AS FLUSHING CATHETER WITH HEPARINIZED SALINE, BUT IT DID NOT WORK. HE DECIDED TO REMOVE PTD BASKET SURGICALLY. HE STATED THAT HE USED THE PTD DEVICE BY ARROW PTD PROCEDURE INSTRUCTIONS & THE THROMBUS, WHICH FORMED IN AV GRAFT, WAS ACUTE THROMBUS & THEREFORE IT WAS NOT HARD OR DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERC. THROMBOLYTIC DEVICE KIT PTD PRODUCTS DXE ARROW INTERNATIONAL INC. MF8082547

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention