BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 2994084 · Received March 8, 2013

    Report

    Report Number
    2134265-2013-01723
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 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

    DEVICE EVALUATED BY MFR: THE EMERGE CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE ALIGNED WITH THE PROXIMAL EDGE OF THE MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS MID OF RIGHT CORONARY ARTERY. AN 8MM X 1.20MM EMERGE BALLOON CATHETER WAS USED FOR PRE DILATION OF THE LESION. THE BALLOON WAS INFLATED TWICE WITH UNKNOWN PRESSURE. UPON 3RD INFLATION AT 8ATM, THE BALLOON RUPTURED. 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 DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS MID OF RIGHT CORONARY ARTERY. AN 8MM X 1.20MM EMERGE BALLOON CATHETER WAS USED FOR PRE DILATION OF THE LESION. THE BALLOON WAS INFLATED TWICE WITH UNKNOWN PRESSURE. UPON 3RD INFLATION AT 8ATM, THE BALLOON RUPTURED. 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
    98966 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919308120 15709965

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR GUIDE WIRE: XTR (ASAHI INTECC)| INFLATION DEVICE: ST. JUDE MEDICAL