BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER

    MDR report key: 1624640 · Received March 5, 2010

    Report

    Report Number
    2183460-2010-00004
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    February 6, 2010
    Report Date
    March 5, 2010
    Manufacturer
    MEDRAD INTERVENTIONAL / POSSIS
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF BROKEN DEVICE DURING ANGIOJET THERAPY. THE PATIENT IS A (B)(6) MALE, WHO WAS UNDERGOING TREATMENT OF A FEM-POP BYPASS GRAFT. THE HOSPITAL STAFF DESCRIBED THE BYPASS GRAFT AS EXTREMELY CALCIFIED THROUGHOUT THE GRAFT. THE SCRUB TECHNICIAN STATED THAT THE PHYSICIAN ATTEMPTED TO PASS THE ANGIOJET CATHETER THROUGH THE DISTAL ANASTOMOSIS AND HAD A LOT OF RESISTANCE. THE PHYSICIAN WENT TO PULL THE ANGIOJET CATHETER BACK BUT ENCOUNTERED A LOT OF RESISTANCE AND NOTICED THAT THE 2 TREATMENT MARKERS WERE STILL IN THE GRAFT. THE TECHNICIAN DESCRIBED THE PART OF THE CATHETER THAT CAME OUT LOOKED AS THOUGH IT HAD BEEN STRETCHED AND THE DISTAL END OF THE CATHETER WAS MISSING. THE TECHNICIAN EXPLAINED THAT THEY DID ADDITIONAL ANGIOGRAPHY'S DOCUMENTING THE MARKERS WERE WITHIN THE GRAFT. THE TECHNICIAN STATED THAT THE PHYSICIAN MADE NO ATTEMPT TO REMOVE WHAT APPEARED TO BE THE VERY DISTAL END OF THE CATHETER FROM THE GRAFT. THE CASE CONTINUED AND THEY OBSERVED THE BROKEN END OF THE CATHETER SLOWLY MOVING DISTAL AS THE CASE PROGRESSED. THE TECHNICIAN STATED THEY PROCEEDED WITH THE CASE AND OPENED ANOTHER ANGIOJET CATHETER WHICH PASSED THROUGH THE GRAFT AND WORKED FINE. THE PHYSICIAN STATED THAT AT THE END OF THE CASE THE END OF THE CATHETER WAS IN A COLLATERAL BRANCH OF THE PERONEAL ARTERY. THE PHYSICIAN STATED IT WAS NOT LIMITING BLOOD FLOW, SO THE PHYSICIAN BALLOON THE TIP UP AGAINST THE COLLATERAL ARTERIAL WALL AND DID NOT ATTEMPT TO REMOVE IT. 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 CATHETER HAS NOT BEEN RETURNED YET AT THE TIME OF THIS REPORT. THIS EVENT IS CONSIDERED A REPORTABLE EVENT AS INTERVENTION WAS REQUIRED TO BALLOON THE DISTAL TIP AGAINST THE COLLATERAL ATRIAL WALL.

    Description of Event or Problem · 1

    STAFF STATED THAT THEY WERE TREATING A FEM-POP BYPASS GRAFT WHICH THEY DESCRIBED AS EXTREMELY CALCIFIED THROUGHOUT THE GRAFT. SCRUB TECH STATED THAT THEY ATTEMPTED TO PASS THE AJ CATHETER THROUGH THE DISTAL ANASTOMOSIS AND HAD A LOT OF DIFFICULTY. THEY WENT TO PULL THE AJ CATHETER BACK WITH A LOT OF RESISTANCE AND NOTICED THAT THE 2 TREATMENT MARKERS WERE STILL IN THE GRAFT. THE SCRUB TECH DESCRIBED THE PART OF THE CATHETER THAT CAME OUT LOOKED AS THOUGH IT HAD BEEN STRETCHED AND THE DISTAL TIP OF THE CATHETER WAS MISSING. SHE EXPLAINED THAT THEY DID ADDITIONAL ANGIOS DOCUMENTING THE MARKERS WITHIN THE GRAFT. SHE STATED THAT THE MD MADE NO ATTEMPT TO REMOVE WHAT APPEARED TO BE THE DISTAL TIP OF THE CATHETER FROM THE GRAFT. THE CASE CONTINUED AND THEY OBSERVED THE TIP OF THE CATHETER SLOWLY MOVING DISTAL AS THE CASE PROGRESSED. SCRUB TECH SAID THEY PROCEEDED WITH THE CASE AND OPENED ANOTHER XPEEDIOR CATHETER WHICH PASSED THROUGH THE GRAFT AND WORKED FINE. DR. (B)(6) STATED THAT AT THE END OF THE CASE, THE TIP WAS IN A COLLATERAL BRANCH OF THE PERONEAL ARTERY. HE STATED IT WAS NOT FLOW LIMITING, SO HE BALLOONED IT UP AGAINST THE COLLATERAL ARTERIAL WALL AND DID NOT ATTEMPT TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER EMBOLECTOMY CATHETER DXE MEDRAD INTERVENTIONAL / POSSIS 105040-001 97438

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention