BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 1242600 · Received November 24, 2008

    Report

    Report Number
    3004742232-2008-00016
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RELATED TO MEDICAL DEVICE MANUFACTURER'S REPORT # 3004742232-2008-00017. IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY TREATMENT PROCEDURE, THE TIP OF THE GUIDE WIRE FRACTURED AND A PORTION REMAINS IN THE PATIENT'S BODY. THE PHYSICIAN HAD SUCCESSFULLY COMPLETED HIS INTERVENTION IN THE DISTAL POST TIBIAL (PT) ARTERY, BUT DECIDED TO ATTEMPT ADDITIONAL INTERVENTION IN THE DORSALIS PEDIS (DP) ARTERY AS WELL. HE DEFERRED USE OF FLUOROSCOPY PRIOR TO ADVANCING INTO THE DP REGION AND SPUN OVER THE DISTAL TIP OF THE VIPERWIRE DESPITE WARNINGS TO THE CONTRARY FROM THE DSM. THE TIP OF THE GUIDE WIRE FRACTURED OFF INTO TWO PIECES. ONE PIECE OF THE WIRE TIP WAS SUCCESSFULLY REMOVED, BUT THE OTHER PIECE REMAINS IN THE PATIENT'S FOOT. THE PHYSICIAN HAD BEEN CAUTIONED NOT TO ADVANCE FURTHER DISTALLY DUE TO THE RISK OF A WIRE FRACTURE, BUT ELECTED TO PROCEED. A SUGGESTION WAS MADE TO ATTEMPT TO SNARE THE RETAINED PORTION OF WIRE, BUT THE PHYSICIAN DECLINED. HE ELECTED TO PERFORMED BALLOON ANGIOPLASTY AND CONFIRMED GOOD FLOW WITH ANGIOGRAM POST-INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS INCORPORATED DB-SC-175L 18590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R