BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA?

    MDR report key: 3981188 · Received August 5, 2014

    Report

    Report Number
    2134265-2014-04895
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF AN OMEGA SDS WITH STENT. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON. MICROSCOPIC EXAMINATION PRESENTED NO DAMAGE OR IRREGULARITIES IN THE STENT, TO THE BALLOON OR BALLOON MATERIAL, TO THE TIP OF THE DEVICE, IN THE MARKERBANDS OR IN THE BONDS OR WELDS OF THE DEVICE. MICROSCOPIC EXAMINATION REVEALED THAT THERE WERE NUMEROUS KINKS THROUGHOUT THE HYPOTUBE OF THE DEVICE. THE MIDSHAFT WAS SEPARATED 1.3CM PROXIMAL OF THE EXIT NOTCH. THE SEPARATED ENDS HAD PULLED AND JAGGED MATERIAL. THE OUTER AND INNER SHAFTS WERE STRETCHED (NECKED DOWN) 2.5MM DISTAL OF THE EXIT NOTCH FOR 4MM. THE INNER SHAFT WAS BUCKLED 3MM ¿ 3.5MM DISTAL OF THE BI-COMPONENT WELD. DEVICE ANALYSIS DETERMINED THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT FOR THE SEPARATION. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER 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 FRACTURE OCCURED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AN ATTEMPT TO PLACE THE 2.5 X 20 OMEGA STENT WAS MADE BUT WAS UNABLE TO CROSS THE LESION. DURING THE PROCEDURE, IT WAS NOTED THAT THE HYPOTUBE FRACTURED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED U.S. DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAFT FRACTURE OCCURED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AN ATTEMPT TO PLACE THE 2.5 X 20 OMEGA STENT WAS MADE BUT WAS UNABLE TO CROSS THE LESION. DURING THE PROCEDURE, IT WAS NOTED THAT THE HYPOTUBE FRACTURED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE 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
    458475 OMEGA? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913820250 15675506

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR