BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3984345 · Received August 6, 2014

    Report

    Report Number
    2134265-2014-04623
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    June 18, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER. THERE WAS CONTRAST IN THE INFLATION LUMEN. THERE WERE NUMEROUS KINKS THROUGHOUT THE HYPOTUBE. THE MIDSHAFT WAS SEPARATED AT THE GUIDEWIRE EXIT NOTCH. THE SHAFT WAS NECKED-DOWN AND STRETCHED 3MM IN LENGTH 5MM DISTAL OF THE GUIDEWIRE EXIT NOTCH. THE SHAFT WAS STRETCHED AND BUCKLED 6.5MM FROM THE DISTAL END. THE DISTAL END OF THE DEVICE WAS NOT RETURNED FOR ANALYSIS. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, 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 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 TIP DETACHMENT OCCURRED. A 15MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE PROCEDURE, THE CATHETER "RIPPED" AND THE TIP DETACHED. ATTEMPTS TO SNARE THE DETACHED PORTION WERE UNSUCCESSFUL. A STENT WAS IMPLANTED OVER THE DETACHED PORTION THAT WAS STUCK IN THE VESSEL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 15MM X 3.50MM NC QUANTUM APEX¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE PROCEDURE, THE CATHETER "RIPPED" AND THE TIP DETACHED. ATTEMPTS TO SNARE THE DETACHED PORTION WERE UNSUCCESSFUL. A STENT WAS IMPLANTED OVER THE DETACHED PORTION THAT WAS STUCK IN THE VESSEL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461845 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415350 16969800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention