BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA?

    MDR report key: 4093771 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05516
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: : A VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE RETURNED PRODUCT CONSISTED OF AN OMEGA SDS WITH STENT. THERE WAS CONTRAST AND BLOOD IN THE INFLATION LUMEN. THERE WAS BLOOD IN THE GUIDEWIRE LUMEN, BALLOON, AND BETWEEN THE BALLOON FOLDS/STENT. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. THE DISTAL TIP WAS DAMAGED. MICROSCOPIC EXAMINATION AND TACTILE INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES TO THE HYPOTUBE SHAFT. MICROSCOPIC EXAMINATION AND TACTILE INSPECTION REVEALED THAT THE OUTER SHAFT WAS SCRATCHED, KINKED, AND HAD HOLES WITH RAISED MATERIAL STARTING AT THE PROXIMAL BALLOON BOND TO 2.2CM PROXIMALLY. MICROSCOPIC EXAMINATION INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES TO THE BONDS OF THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY ATTACHING AN INFLATION DEVICE FILLED WITH WATER TO THE DEVICE. WHEN POSITIVE PRESSURE WAS APPLIED, A STREAM OF WATER EMITTED FROM THE SHAFT WALL AT THE AREA OF THE DAMAGE. DEVICE ANALYSIS OF THE RETURNED DEVICE IS CONSISTENT WITH THE REPORTED EVENT. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER DAMAGE OR ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 2.25X24MM TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHILE PERFORMING A PERCUTANEOUS CORONARY INTERVENTION, THE PROXIMAL SHAFT OF THE 3.50 X 20 OMEGA STENT DELIVERY SYSTEM BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. THE 2.25X24MM TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHILE PERFORMING A PERCUTANEOUS CORONARY INTERVENTION, THE PROXIMAL SHAFT OF THE 3.50 X 20 OMEGA STENT DELIVERY SYSTEM BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573649 OMEGA? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913820350 16551719

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR