BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V18 CONTROL WIRE

    MDR report key: 855150 · Received May 23, 2007

    Report

    Report Number
    6000130-2007-00106
    Event Type
    Injury
    Date Received
    May 23, 2007
    Date of Event
    April 25, 2007
    Report Date
    April 25, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K)# K934359.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A GUIDEWIRE TIP FRACTURE OCCURED. THE CALCIFIED, 100% STENOTIC LESION WAS LOCATED IN THE LEFT COMMON ILIAC/EXTERNAL ILIAC ARTERY WHICH EXHIBITED AVERAGE TORTUOSITY. THE GUIDE WIRE WAS INSERTED THROUGH A 6F SHEATH FROM AN IPSILATERAL APPROACH, BUT WAS NOT ABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO APPROACH THE LESION FROM A CONTRALATERAL POSITION USING A 5F CATHETER AND MICRO CATHETER INSERTED IN A 6F SHEATH FOR BACK UP. IT WAS STILL NOT POSSIBLE TO CROSS THE LESION. "WHEN THE PHYSICIAN TRIED TO REMOVE THE GUIDEWIRE, IT'S DISTAL TIP WAS SEPARATED OFF ON THE BIFURCATION." THE DISTAL TIP WAS RETRIEVED WITH A SNARE AND THE PROCEDURE WAS DISCONTINUED. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "GOOD AND NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V18 CONTROL WIRE DQX BOSTON SCIENTIFIC CORPORATION NA 8815998

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention 5F CATHETER AND MICRO CATHETER| 6F MEDIKIT SHEATH