BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1161454 · Received September 12, 2008

    Report

    Report Number
    1016427-2008-00242
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AFTER SUCCESSFULLY PLACING A STENT IN THE INTERNAL AND COMMON CAROTID ARTERY, THE PHYSICIAN HAD DIFFICULTY CAPTURING THE ANGIOGUARD FILTER BASKET SUBSEQUENTLY CAUSING THE FILTER BASKET TO TEAR. THE PT IS A MALE. THE TARGET VESSEL WAS DESCRIBED AS MILDLY CALCIFIED AND HEAVILY TORTUOUS. THE RATE OF STENOSIS WAS 75% . THERE WAS NO DIFFICULTY POSITIONING THE FILTER BASKET DISTAL TO THE LESION. THERE WAS NO DIFFICULTY PLACING THE STENT. THE STENT WAS POST-DILATED AND THERE WAS GOOD VESSEL WALL APPOSITION FOLLOWING POST-DILATION. WHEN THE PHYSICIAN ADVANCED THE CAPTURE SHEATH AND ATTEMPTED TO CROSS OVER TO THE LESION, IT GOT HUNG UP WITH THE DISTAL TIP OF THE STENT. THE PHYSICIAN MANAGED TO CROSS THE TARGET LESION BY CHANGING HIS ANGLE OF APPROACH. THE FILTER BASKET WAS CAPTURED, BUT NOT CAPTURED PROPERLY. HE CONTINUED TO WITHDRAW THE DEVICE, HOWEVER, PART OF THE FILTER BASKET GOT HUNG UP WITH THE PROXIMAL SIDE OF THE STENT. THE PHYSICIAN MANAGED TO REMOVE THE FILTER BASKET CAREFULLY BY SLOWLY GIVING TENSION. AFTER THE REMOVAL OF THE PRODUCT, THE FILTER BASKET WAS INSPECTED AND IT WAS NOTICED THAT IT HAD RIPPED, AND WAS TURNED INSIDE OUT. ALSO THE TIP OF THE CAPTURE SHEATH HAD BEEN SLIGHTLY TURNED OUTWARD. THE PHYSICIAN NOTED THAT WHEN THE CAPTURE SHEATH GOT HUNG UP WITH THE DISTAL TIP OF THE STENT DURING APPROACH, IT MIGHT HAVE BEEN TURN OUTWARD. THEN DURING REMOVAL, A PART OF THE BASKET GOT HUNG UP WITH THE STENT AND WAS TURNED OUTWARD. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70907502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GC: BRITETIP (8F| INDEFLATOR: EVEREST/ MEDTRONIC| BC: AMIIA (PRE: DIAMETER 4MM 4CM| GW: DEJAVU (180CM)| 5MM 2CM)| STENT: PRECISE (P10040XC