BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC MERLIN PTCA CATHETER (OTW)

    MDR report key: 1073707 · Received July 1, 2008

    Report

    Report Number
    2024168-2008-00535
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 4, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P910031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, IT CAN BE ASSUMED THAT THE DEVICE WAS IN WORKING ORDER AND LEFT ABBOTT VASCULAR INSTRUMENTS AS PER SPECIFICATIONS. DURING THE INVESTIGATION OF THE PRODUCTION RECORDS, INDICATIONS OF ANY MANUFACTURING ISSUE ON THE MANUFACTURED DEVICES IN THIS PRODUCTION LOT COULD NOT BE FOUND. DUE TO THE FACT THAT THE DEVICE WAS NOT SENT BACK FOR INVESTIGATION, THE ROOT CAUSE FOR THE FAILURE COULD NOT BE FOUND.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS CONSIDERED LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE MERLIN WAS BEING USED TO TREAT AN IN-STENT RESTENOSIS IN THE RCA. THE BALLOON RUPTURED AT 18 ATM. ANOTHER COMPANY'S BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC MERLIN PTCA CATHETER (OTW) LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 449080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DILITATION CATHETER: BOSTON SCIENTIFIC FALCON