BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 2994118 · Received March 8, 2013

    Report

    Report Number
    2134265-2013-01729
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    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

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION LOCATION WAS UNKNOWN. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON OF THE 3.00X15MM EMERGE MONORAIL CATHETER "THROUGH THE STENT STRUTS." DURING INFLATION, THE BALLOON RUPTURED. THE NUMBER OF INFLATIONS AND TO WHAT ATMS WAS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 90% STENOSED CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS FIRST DIAGONAL OF LEFT ANTERIOR DESCENDING ARTERY. UPON FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE DEVICE REMOVED WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99321 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315300 15650492

    Patients

    Seq Age Sex Outcome Treatment
    1