BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER

    MDR report key: 1633226 · Received March 16, 2010

    Report

    Report Number
    2183460-2010-00005
    Event Type
    Other
    Date Received
    March 16, 2010
    Date of Event
    February 17, 2010
    Report Date
    March 16, 2010
    Manufacturer
    MEDRAD INTERVENTIONAL / POSSIS
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF BROKEN DEVICE DURING ANGIOJET THERAPY. THE PT IS A FEMALE WHO HAD UNDERGONE TREATMENT USING AN ANGIOJET CATHETER. THE PHYSICIAN FELT RESISTANCE WHEN REMOVING THE ANGIOJET CATHETER FROM THE GROIN. AFTER PULLING ON THE CATHETER, IT WAS NOTICED THAT THE VERY DISTAL END WENT DOWN THE ARTERY. THE PHYSICIAN THEN USED A SNARE TO CAPTURE AND REMOVE IT. IT WAS STATED THE CASE WENT WELL AND THE PT HAD NO SEQUELAE. THE IFU WARNS THE USER "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." THE EVENT IS CONSIDERED A REPORTABLE EVENT AS INTERVENTION WAS REQUIRED TO RETRIEVE THE DISTAL TIP. THE CUSTOMER SITE STATED, THE PHYSICIAN FELT RESISTANCE WHEN REMOVING ANGIOJET CATHETER FROM GROIN. AFTER PULLING, NOTICED THE DISTAL TIP WENT DOWN AN ARTERY. PHYSICIAN THEN USED EV3 SNARE TO REMOVE. INSPECTED THE RETURNED AVX CATHETER AND OBSERVED THAT THE TIP WAS STRETCHED, DAMAGED, AND SEPARATED FROM THE CATHETER. OPERATED THE CATHETER WITH TEST PUMP AND KNOWN GOOD GEN II DRIVE UNIT AND THERE WERE NO ALARMS OBSERVED. DUE TO THE DAMAGE OBSERVED AT THE TIP OF THE CATHETER, THE CUSTOMER WOULD NOT HAVE BEEN ABLE TO CONTINUE THE PROCEDURE.

    Description of Event or Problem · 1

    DR. FELT RESISTANCE WHEN REMOVING ANGIOJET CATHETER FROM GROIN. AFTER PULLING, NOTICED THE DISTAL TIP WENT DOWN ARTERY. PHYSICIAN THEN USED EV3 SNARE TO REMOVE. PT AND CASE DID WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER EMBOLECTOMY CATHETER DXE MEDRAD INTERVENTIONAL / POSSIS 104529-001 97631

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention