BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2161915 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-03085
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 14, 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

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED BLOOD IN THE LUMEN AND BALLOON. THE BALLOON WAS DISTENDED DISTALLY, EXTENDING BEYOND THE DISTAL BALLOON BOND. THE MARKER BAND SPACING WAS WITHIN SPECIFICATION. THE OUTER SHAFT WAS TORN LONGITUDINALLY PROXIMAL OF THE PROXIMAL WELD. MAGNIFIED INSPECTION REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0X24 PROMUS ELEMENT STENT WAS IMPLANTED IN THE LESION WITHOUT ISSUE AND THE 3.5X8.0MM NC QUANTUM APEX BALLOON CATHETER WAS THEN ADVANCED FOR POST-DILATION OF THE STENT. DURING THE FIRST INFLATION, THE BALLOON WAS INFLATED TO "14 BAR"; HOWEVER, IT APPEARED THAT BALLOON MATERIAL ON THE SHAFT, PROXIMAL TO THE BALLOON ITSELF, WAS EXPANDING IN ADDITION TO THE ACTUAL BALLOON. THE DEVICE WAS REMOVED AND THE ISSUE WAS DUPLICATED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0X24 PROMUS ELEMENT STENT WAS IMPLANTED IN THE LESION WITHOUT ISSUE AND THE 3.5X8.0MM NC QUANTUM APEX BALLOON CATHETER WAS THEN ADVANCED FOR POST-DILATION OF THE STENT. DURING THE FIRST INFLATION, THE BALLOON WAS INFLATED TO "14 BAR"; HOWEVER, IT APPEARED THAT BALLOON MATERIAL ON THE SHAFT, PROXIMAL TO THE BALLOON ITSELF, WAS EXPANDING IN ADDITION TO THE ACTUAL BALLOON. THE DEVICE WAS REMOVED AND THE ISSUE WAS DUPLICATED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

    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 H7493912408350 14247397

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR