BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2021755 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00866
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 18, 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.: 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 OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, DEVICE STUCK ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED THROUGH A FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE 2.5MM X 15MM NC QUANTUM APEX BALLOON CATHETER ON AN UNSPECIFIED GUIDE WIRE HOWEVER; RESISTANCE WAS ENCOUNTERED. THE BALLOON BECAME STUCK ON THE GUIDE WIRE AND THE TWO DEVICES WERE REMOVED FROM THE PATIENT AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 H7493912415250 13846419

    Patients

    Seq Age Sex Outcome Treatment
    1