BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2032631 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01144
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MFR.: 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 A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). ROTATIONAL ATHERECTOMY WAS SUCCESSFULLY PERFORMED AND A 3.5 X 28MM PROMUS STENT WAS IMPLANTED. FOR POST DILATION THE 4.0MM X 15MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED TO 20ATMS AND THEN BECAME STUCK ON THE NON-BSC GUIDE WIRE. THE GUIDE WIRE AND THE BALLOON CATHETER WERE REMOVED FROM THE PATIENT TOGETHER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 H7493912415400 13770701

    Patients

    Seq Age Sex Outcome Treatment
    1 3.5 X 28MM PROMUS STENT| MACH1 8F GUIDE CATHETER| SJM SION BLUE GUIDE WIRE| ENCORE INFLATION DEVICE