BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET AVX THROMBECTOMY CATHETER

    MDR report key: 2823708 · Received October 25, 2012

    Report

    Report Number
    2183460-2012-00020
    Event Type
    Other
    Date Received
    October 25, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SITE STATED THAT THE TIP CAME OFF OF THE CATHETER WHILE IN THE BODY. IT WAS SNARED AND RETRIEVED. VISUALLY INSPECTED THE ULTRA AVX THROMBECTOMY SET AND OBSERVED THE WINDOWS WERE STRETCHED AND DAMAGED AND THE TIP HAD BEEN REMOVED AND WAS NOT RETURNED. FUNCTIONALLY TESTED THE THROMBECTOMY SET, WHICH RAN AT A HIGHER PRESSURE. PERFORMANCE ISSUES WOULD HAVE BEEN EXPERIENCED AT THE CUSTOMER SITE. REGULATORY SUMMARY: EVENT CONSISTS OF A BROKEN DEVICE DURING AN ANGIOJET PROCEDURE. THE PT'S GENDER AND AGE ARE UNK AS WELL AS ANY PT MEDICAL HISTORY. DURING AN THROMBECTOMY PROCEDURE WITH AN ANGIOJET ULTRA AVX THROMBECTOMY SET, THE TIP OF THE CATHETER BROKE OFF WHILE IN THE PT'S BODY. THE BROKEN TIP WAS SNARED AND RETRIEVED FROM THE PT. THE PT WAS REPORTED TO BE FINE WITH NO SEQUELA. THE IFU WARNS THE USER: "VISUALLY INSPECT THE THROMBECTOMY SET PRIOR TO USE TO ENSURE THAT NO DAMAGE HAS OCCURRED DURING SHIPMENT. DO NOT ATTEMPT TO STRAIGHTEN OR USE THE CATHETER IF IT IS BENT OR KINKED. ATTEMPTING TO DO SO MAY RESULT IN CATHETER RUPTURE. DO NOT USE A DAMAGED THROMBECTOMY SET FOR PT TREATMENT. "DURING THE PROCEDURE, DO NOT RETRACT THE GUIDE WIRE INTO THE CATHETER. IF RETRACTION OF THE GUIDE WIRE INTO THE CATHETER OCCURS, IT MAY BE NECESSARY TO REMOVE BOTH THE CATHETER AND GUIDE WIRE FROM THE PT IN ORDER TO RE-LOAD THE CATHETER OVER THE GUIDE WIRE." "IF RESISTANCE IS FELT DURING THE ADVANCEMENT OF THE THROMBECTOMY SET TO LESION SITE, DO NOT FORCE OR TORQUE THE CATHETER EXCESSIVELY AS THIS MAY RESULT IN DEFORMATION OF TIP COMPONENTS AND THEREBY DEGRADE CATHETER PERFORMANCE." "DO NOT PULL THE CATHETER AGAINST ABNORMAL RESISTANCE IF INCREASED RESISTANCE IS FELT WHEN REMOVING THE CATHETER, REMOVE THE CATHETER TOGETHER WITH THE SHEATH OR GUIDE CATHETER AS A UNIT TO PREVENT POSSIBLE TIP SEPARATION." THIS EVENT IS CONSIDERED A REPORTABLE EVENT AS INTERVENTION WAS REQUIRED TO SNARE AND RETRIEVE THE BROKEN PORTION OF THE ANGIOJET DEVICE.

    Description of Event or Problem · 1

    THE TIP CAME OFF OF THE CATHETER WHILE IN THE BODY. IT WAS SNARED AND RETRIEVED. THE PT IS FINE. CATH EVENT AT (B)(6) HOSP, PLACES ALL ORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX THROMBECTOMY CATHETER EMBOLECTOMY CATHETER DXE BAYER INTERVENTIONAL, INC. 105039-001 106577

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention