BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3180421 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04743
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PREPARATION FOR AN ANGIOPLASTY TREATMENT PROCEDURE, SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE UNSPECIFIED ARTERY. A 12 MM X 2.50 MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED BUT WAS NOT INTRODUCED INSIDE THE PATIENT BECAUSE THE PHYSICIAN BROKE IT. SALES REPRESENTATIVE STATED THAT HE HAS A LIMITED INFORMATION REGARDING THE EVENT AND ALL HE HAS WAS A BOX WITH A NOTE, AND THESE ARE ALL THE INFORMATION HE PROVIDED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE BREAK OCCURRED IN THE HUB AND THAT THERE WAS NO COMPLETE COMPONENT SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279879 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412250 15761794

    Patients

    Seq Age Sex Outcome Treatment
    1