BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC EMERGE®

    MDR report key: 7088422 · Received December 6, 2017

    Report

    Report Number
    2134265-2017-12181
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    November 16, 2017
    Report Date
    December 20, 2017
    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

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULTS CODES AND CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A NC EMERGE BALLOON CATHETER. THE BALLOON WAS LOOSELY FOLDED WITH BLOOD IN THE INFLATION LUMEN AND BALLOON. MICROSCOPIC EXAMINATION REVEALED THAT THE BALLOON HAS 7 SMALL PINHOLES IN A ROW AT THE PROXIMAL MARKERBAND. THE TIP IS DAMAGED. THERE IS SHAFT DAMAGE AT THE EXIT NOTCH THAT IS CONSISTENT WITH DAMAGE SEEN WITH THE USE OF A GUIDEWIRE. THERE ARE NUMEROUS HYPOTUBE AND SHAFT KINKS. THERE IS NO INDICATION THE DEVICE WAS INFLATED OVER RBP. 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. BSC ID #: (B)(4). TW#: 4880988.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.25MM X 8MM NC EMERGE® BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FORM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.25MM X 8MM NC EMERGE® BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FORM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866492 NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493927608320 0019572130

    Patients

    Seq Age Sex Outcome Treatment
    1