BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 2140899 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02486
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    June 2, 2011
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. WHILE ADVANCING A NC QUANTUM APEX BALLOON TO THE UNSPECIFIED TARGET LESION LOCATION, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN THOUGHT THE BALLOON MAY HAVE GOTTEN CAUGHT ON A STENT STRUT DURING ADVANCEMENT AS THE BALLOON FAILED TO INFLATE WHEN IT REACHED THE LESION LOCATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER NC QUANTUM APEX BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX UNK651

    Patients

    Seq Age Sex Outcome Treatment
    1