BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-CROSS SELECT SUPPORT CATHETER

    MDR report key: 1938870 · Received December 17, 2010

    Report

    Report Number
    1721279-2010-00085
    Event Type
    Death
    Date Received
    December 17, 2010
    Date of Event
    September 26, 2010
    Report Date
    November 19, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DQY
    PMA / PMN Number
    K092396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RECEIVED A BRIEF EXPLANATION FROM THE FDA OF A CASE INVOLVING A SPECTRANETICS DEVICE (QC-SELECT) REPORTED ON 10/18/2010 BY (B)(6) HOSPITAL. THE EVENT DESCRIPTION STATES "DISTAL PART OF CATHETER BROKE OFF IN PATIENT 'STEM' WHILE CARDIOLOGIST WAS PULLING BACK. DIAGNOSIS OR REASON FOR USE: HELPS CROSS BLOCKAGES." MULTIPLE ATTEMPTS (12/02/2010, 12/09/2010, 12/17/2010) HAVE BEEN MADE TO GATHER FURTHER CASE INFORMATION FROM THE HOSPITAL WITHOUT SUCCESS. THE DEVICE WAS NOT RETAINED FOR RETURN ANALYSIS TO THE MANUFACTURER, NOR WAS THE MANUFACTURER NOTIFIED OF THE CASE/PATIENT DEATH. AN INTERNAL LOT HISTORY REVIEW FOUND NO NON-CONFORMANCES OR ISSUES WITH THE DEVICE LOT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-CROSS SELECT SUPPORT CATHETER QCS 0.35 135CM DQY SPECTRANETICS CORP. 518-081 CQX08L20B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death