BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO ELITE LASER ABLATION CATHETER

    MDR report key: 2238395 · Received August 25, 2011

    Report

    Report Number
    1721279-2011-00054
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 9, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DQY
    PMA / PMN Number
    K071227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED A COPY OF AN MDR FROM THE FDA ON (B)(4) 2011 SUBMITTED BY A CUSTOMER CLAIMING "DEVICE MALFUNCTION" OF A TE. THERE WAS NO PT INVOLVEMENT OR INJURY. A PHONE CALL WAS PLACED ON (B)(6) 2011 TO (B)(6) TO INQUIRE FURTHER ABOUT THE CASE. SHE WAS THE "CONTACT PERSON" LISTED ON THE FORM FDA 3500A. SHE REPORTED SHE "DIDN'T REALLY KNOW THE DEVICE, JUST THAT IT MALFUNCTIONED. IT DIDN'T DO WHAT IT WAS SUPPOSED TO DO." THE CASE WAS REPORTED AS OCCURRING ON (B)(6) 2011. THE (B)(4) REP WAS THEN CALLED. SHE STATED SHE REMEMBERED THIS HAPPENING AND IT WAS WELL OVER A YEAR AGO. THE (B)(4) REP THEN CALLED AND SPOKE TO THE CATH LAB MANAGER AT (B)(6). THE MANAGER CONFIRMED "THAT HAPPENED A LONG TIME AGO. I DON'T KNOW WHY OR WHO WOULD HAVE REPORTED IT AS A MALFUNCTION? I KNOW NONE OF US IN THE LAB DID." THERE WAS NO OTHER CASE DETAIL PROVIDED TO THE MFR, NOR WAS THERE A RECORD OF A DEVICE MALFUNCTION OCCURRING AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBO ELITE LASER ABLATION CATHETER 1.4 OTW TE DQY SPECTRANETICS CORP. 414-151 F11C14E

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR