BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 2022307 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00776
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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 USER RELATED AS THE DEVICE WAS INFLATED ABOVE ITS' RATED BURST PRESSURE, WHICH CONTRADICTS THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 85% STENOSED, ECCENTRIC SHAPED, LESS THAN 15MM, DE-NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED, 3.25MM IN DIAMETER, PROXIMAL RIGHT CORONARY ARTERY (RCA). THIS 2.50X15MM APEX BALLOON CATHETER WAS SELECTED FOR PRE-DILATION. THE BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND THE BALLOON WAS INFLATED. THE PLAQUE DID NOT YIELD, SO THE PHYSICIAN CONTINUED TO INFLATE THE BALLOON PAST RATED BURST PRESSURE, AT WHICH POINT THE BALLOON RUPTURED. PRE-DILATION WAS COMPLETED WITH ANOTHER BALLOON RESULTING IN 0% STENOSIS. THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF A PROMUS STENT AND POST-DILATION WITH A 3.5X15MM NC QUANTUM APEX BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895915250 14061073

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR BMW GUIDE WIRE