BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.3MM CATHETER OVER-THE-WIRE

    MDR report key: 1240904 · Received November 5, 2008

    Report

    Report Number
    1721279-2008-00043
    Event Type
    Other
    Date Received
    November 5, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 5, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT OUTCOME: THE PT WAS KEPT OVERNIGHT AND DISCHARGED HOME THE FOLLOWING DAY. PRELIMINARY FAILURE ANALYSIS: THERE IS NO INDICATION THAT THE EVENT WAS CAUSED BY A MALFUNCTION OF THE SPNC DEVICE. CORRECTION: BRAND NAME. THE INITIAL FILING DOCUMENTED THE "BRAND NAME" AS BEING A 2.0MM CATHETER OVER-THE-WIRE. THE ACTUAL AND CORRECT BRAND NAME OF THIS DEVICE IS SPNC 2.3MM CATHETER OVER-THE-WIRE.

    Description of Event or Problem · 1

    CLINICAL HISTORY: PT IS A (B) (6) FEMALE PRESENTING WITH A COMPLETE, TOTAL OCCLUSION OF THE SFA. PROCEDURE: DR (B) (6) TRIED USING A QUICK CROSS DEVICE WITH A WIRE TO CROSS THE LESION WITHOUT SUCCESS. DR (B) (6) IN TO ASSIST DR (B) (6) PASSED A PIONEER CATHETER WITH WIRE SUCCESSFULLY THROUGH THE LESION, DOWN TO THE KNEE. DR (B) (6) THEN REMOVED THE PIONEER CATHETER AND PLACED A 2.3 TE. DR (B) (6) PROCEEDED TO LASE WITH THE 2.3 TE, ASSUMING THE GUIDE WIRE WAS IN THE APPROPRIATE PLACE. FLURO WAS USED THROUGHOUT THE PROCEDURE. A MEMBER OF THE TEAM NOTICED A BLUE LIGHT COMING FROM UNDERNEATH THE STERILE DRAPE. THE MD HAD LASED COMPLETELY THROUGH THE PT'S THIGH, AS THE GUIDEWIRE HAD BEEN RETRACTED FOR AN UNK REASON. THE PT DID NOT COMPLAIN OF ANY PAIN AROUND THE SITE DURING THE PROCEDURE, VITALS WERE STABLE THROUGHOUT, A NURSE HELD DIRECT PRESSURE AT THE SITE OF THE EXIT WOUND AND BLEEDING STOPPED. A POST-PROCEDURE ANGIOGRAM WAS DONE AND SHOWED NO OBVIOUS INJURY TO THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.3MM CATHETER OVER-THE-WIRE 2.3 OTW GEX SPECTRANETICS CORP. 423-001 CO8H28B

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention SPECTRANETICS CVX-300 LASER