BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2872441 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-08005
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN INFLATED A 12 MM X 3.00 MM NC QUANTUM APEX BALLOON CATHETER IN THE TARGET LESION HOWEVER THE BALLOON RUPTURED. THEN THE PHYSICIAN INFLATED A SECOND 12 MM X 3.00 MM NC QUANTUM APEX BALLOON CATHETER IN THE TARGET LESION HOWEVER IT ALSO RUPTURED. THE DEVICES WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412300 15612590

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MM X 3.00 MM NC QUANTUM APEX BALLOON CATHETER