BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3782090 · Received April 30, 2014

    Report

    Report Number
    2134265-2014-02435
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER WITH A NC QUANTUM APEX SHELF BOX . THE BATCH NUMBER ON THE PACKAGING AND DEVICE MATCHED THE REPORTED BATCH. THERE WAS A NON-BSC GUIDEWIRE IN THE WIRE LUMEN. THERE WAS BLOOD IN THE WIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE MULTIPLE HYPOTUBE KINKS. THE HYPOTUBE WAS FRACTURED 66.5CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 15MM X 3.00MM NC QUANTUM APEX¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING WITHDRAWING OF THE DEVICE, IT WAS NOTICED THAT IT WAS BROKEN ABOUT MID SHAFT OF THE DEVICE. THE DEVICE WAS REMOVED OVER THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 15MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING WITHDRAWING OF THE DEVICE, IT WAS NOTICED THAT IT WAS BROKEN ABOUT MID SHAFT OF THE DEVICE. THE DEVICE WAS REMOVED OVER THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260623 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415300 16612061

    Patients

    Seq Age Sex Outcome Treatment
    1