BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2141783 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02752
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    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 UNSPECIFIED TREATMENT PROCEDURE A BALLOON PINHOLE WAS NOTED. THE LESION WAS LOCATED IN A VERY CALCIFIED AND NON TORTUOUS RIGHT CORONARY ARTERY. ABLATION WAS COMPLETED WITH A 1.5MM ROTABLATOR BURRL. THE PHYSICIAN ATTEMPTED TO PLACE A 3.0X38MM ION STENT; HOWEVER, WAS UNABLE TO CROSS THE LESION. PULLED THE ION STENT OUT AND WENT IN WITH THE 3.0X15MM NC QUANTUM APEX BALLOON. THE BALLOON WAS INFLATED TO TWENTY ATMOSPHERES. ON THE SECOND INFLATION IT WAS NOTED THAT THE BALLOON WOULD NOT HOLD PRESSURE. THERE WAS A HOLE IN THE BALLOON. THE PHYSICIAN WAS ABLE TO DEPLOY THE 3.0X38MM ION STENT SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912515300

    Patients

    Seq Age Sex Outcome Treatment
    1 3.0X38MM ION STENT| 1.5MM ROTABLATOR