BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC EMERGE®

    MDR report key: 5762598 · Received June 30, 2016

    Report

    Report Number
    2134265-2016-05934
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Date of Event
    May 23, 2016
    Report Date
    June 10, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC EMERGE BALLOON CATHETER WITH A GUIDELINER DEVICE. THE BALLOON WAS LOOSELY FOLDED. THERE WAS BLOOD IN THE WIRE LUMEN. THE BALLOON, SHAFT AND TIP WERE MICROSCOPICALLY EXAMINED. THE SHAFT WAS DAMAGED AT THE GUIDEWIRE EXIT NOTCH AND THERE WAS TEFLON CAUGHT IN THE DAMAGE. THE DAMAGE IS CONSISTENT WITH INTERACTION WITH A GUIDEWIRE. THE TIP WAS ALSO DAMAGED. 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JUN2016. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER PREDILATION WAS PERFORMED WITH A 2.0MM NON-BSC BALLOON CATHETER, THE LESION WAS OBSERVED BY INTRAVASCULAR ULTRASOUND (IVUS). THEN A 3.0MMX16MM SYNERGY STENT WAS THEN DEPLOYED AND POST DILATATION WAS PERFORMED WITH 3.0MMX15MM NC EMERGE BALLOON CATHETER. A KISSING BALLOON TECHNIQUE (KDT) WAS ATTEMPTED USING A 2.0X15MM NON-BSC AND A 3.0X15 NC EMERGE BALLOON CATHETERS BUT THE 3.0X15 NC EMERGE BALLOON CATHETER WAS UNABLE TO CROSS THROUGH THE PREVIOUSLY IMPLANTED STENT. THE DEVICE WAS EXCHANGED WITH A 3.0X15 NON-BSC BALLOON CATHETER. THE KBT WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PRESENCE OF A FOREIGN MATTER ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415543 NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493927615300 18312165

    Patients

    Seq Age Sex Outcome Treatment
    1