BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 6321233 · Received February 10, 2017

    Report

    Report Number
    2134265-2017-00950
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 25, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN EMERGE BALLOON CATHETER. THE BALLOON WAS LOOSELY FOLDED AND THERE WAS BLOOD IN THE HUB OF THE DEVICE. THE BALLOON, MARKERBANDS AND TIP OF THE DEVICE WERE MICROSCOPICALLY AND TACTILE INSPECTED. INSPECTION REVEALED NUMEROUS KINKS IN HYPOTUBE OF THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY CONNECTING AN INFLATION DEVICE FILLED WITH WATER TO THE HUB. WATER WAS FOUND TO BE STREAMING FROM A PINHOLE IN THE BALLOON MATERIAL, LOCATED AT THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. INSPECTION OF THE REMAINDER OF THE DEVICE 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 BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. AFTER A 2.5X23 NON-BSC STENT WAS IMPLANTED, THE PHYSICIAN ATTEMPTED TO PERFORM A KISSING BALLOON TECHNIQUE (KBT) USING THE STENT DELIVERY SYSTEM (SDS) BALLOON AND A 2.00MM X 15MM EMERGE¿ BALLOON CATHETER WHICH ENCOUNTERED INSERTION RESISTANCE. THE SDS BALLOON WAS UNABLE TO CROSS THE IMPLANTED STENT AND IT WAS REPLACED WITH A 2.5X15 NON-BSC BALLOON CATHETER TO PERFORM KBT. HOWEVER, THE 2.00MM X 15MM EMERGE¿ BALLOON RUPTURED DURING FIRST INFLATION AND WAS UNABLE TO DILATE. THE DEVICE WAS COMPLETELY REMOVED AND REPLACED WITH ANOTHER 2.00MM X 15MM EMERGE¿ BALLOON CATHETER. KBT WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. AFTER A 2.5X23 NON-BSC STENT WAS IMPLANTED, THE PHYSICIAN ATTEMPTED TO PERFORM A KISSING BALLOON TECHNIQUE (KBT) USING THE STENT DELIVERY SYSTEM (SDS) BALLOON AND A 2.00MM X 15MM EMERGE¿ BALLOON CATHETER WHICH ENCOUNTERED INSERTION RESISTANCE. THE SDS BALLOON WAS UNABLE TO CROSS THE IMPLANTED STENT AND IT WAS REPLACED WITH A 2.5X15 NON-BSC BALLOON CATHETER TO PERFORM KBT. HOWEVER, THE 2.00MM X 15MM EMERGE¿ BALLOON RUPTURED DURING FIRST INFLATION AND WAS UNABLE TO DILATE. THE DEVICE WAS COMPLETELY REMOVED AND REPLACED WITH ANOTHER 2.00MM X 15MM EMERGE¿ BALLOON CATHETER. KBT WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104560 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315200 0018711638

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER: IKAZUCHI2.5/15| GUIDE CATHETER: 6F HYPERION SPB3.5| GUIDEWIRE: SION BLUE, SION BLACK| INFLATION DEVICE: ENCORE| INTRODUCER SHEATH: TERUMO 6| STENT: XIENCE2.5/23