BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 4152776 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-06081
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    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

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF EMERGE BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN. DEVICE ANALYSIS DETERMINED THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. THERE WERE NUMEROUS HYPOTUBE KINKS. MAGNIFIED INSPECTION IDENTIFIED A 3MM LONGITUDINAL TEAR IN THE BALLOON MATERIAL ON THE DISTAL END OF THE BALLOON. MICROSCOPIC EXAMINATION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL AND RO MARKERBANDS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. NO PROXIMAL WELD DAMAGE WAS FOUND. 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).

    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 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25MM X 12MM EMERGE¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO DILATE THE LESION. UPON AN UNKNOWN NUMBER OF INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. NO SEGMENT OF THE BALLOON WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25MM X 12MM EMERGE¿ BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED TO DILATE THE LESION. UPON AN UNKNOWN NUMBER OF INFLATION, THE BALLOON RUPTURED AT 6 ATMOSPHERES. NO SEGMENT OF THE BALLOON WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631234 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919312220 16762948

    Patients

    Seq Age Sex Outcome Treatment
    1