BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2033434 · Received March 24, 2011

    Report

    Report Number
    3004742232-2011-00007
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, THE DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM BECAME STUCK IN THE VESSEL. THE LESION CHARACTERISTICS ARE UNK AT THIS TIME. THE PHYSICIAN USED A 6X90 INTRODUCER SHEATH AND A 0.014X150 QUICKCROSS CATHETER TO CROSS THE TARGET LESION FROM A RETROGRADE APPROACH. HE PRE-DILATED THE PT WITH A 2.0X150 BALLOON PRIOR TO TREATING WITH THE DIAMONDBACK OAD. HE PERFORMED APPROX TWO RUNS AT LOW SPEED IN THE TPT, THEN FIVE RUNS IN THE PT (ONE AT LOW SPEED, FOUR AT MEDIUM SPEED). THE TOTAL TREATMENT TIME WAS 3 MINS, 30SECS. UPON COMPLETION OF TREATMENT OF THE TIBIAL PERONEAL TRUNK (TPT) THEN THE PT, IT WAS DETERMINED THAT THE OUTFLOW VESSELS HAD ALL SHUT DOWN AND THAT THE WIRE WAS PULLING BACK WITH OUR DEVICE. THE CROWN INITIALLY BECAME STUCK IN THE TPT, THEN AGAIN AT THE DISTAL TIP OF THE INTRODUCER SHEATH. THE PHYSICIAN HAD TO REMOVE THE DEVICE WITH SOME FORCE. THE VIPERWIRE BECAME KINKED WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE DEVICE. THERE WAS A PROCEDURE DELAY BECAUSE WIRE ACCESS WAS LOST. AFTER RE-WIRING, THE PHYSICIAN ATTEMPTED PTA, PRONTO CATHETER WAS USED, TPA WAS ADMINISTERED, AND AN INTEGRILIN DRIP WAS STARTED DUE TO NO FLOW BELOW THE KNEE. THE PT LATER REQUIRED A FASCIOTOMY IN THE OPERATING ROOM. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS INCORPORATED DBG-SCT30-125 37800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R GUIDE WIRE CHOICE PT WIRE X5| 2.0X150 NANOCROSS BALLOON| INTRODUCER SHEATH 6X90 RABBE| 0.014 X150 QUICKCROSS CATHETER