BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 7571649 · Received June 5, 2018

    Report

    Report Number
    2134265-2018-04751
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 9, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN AND MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER. THE BALLOON WAS LOOSELY FOLDED. MICROSCOPIC EXAMINATION REVEALED THAT THE BALLOON HAS A PINHOLE 3MM FROM THE DISTAL MARKERBAND. THERE ARE NUMEROUS HYPOTUBE AND SHAFT KINKS. THERE IS SHAFT DAMAGE AT THE EXIT NOTCH THAT IS CONSISTENT WITH DAMAGE SEEN WITH THE USE OF A GUIDEWIRE. THE INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A 20MM X 3.25MM NC QUANTUM APEX¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A 20MM X 3.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412555 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912420320 21523023

    Patients

    Seq Age Sex Outcome Treatment
    1