BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA¿

    MDR report key: 2983144 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01216
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 4, 2013
    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

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED A HYPOTUBE SEPARATION 20CM FROM THE EDGE OF THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACE WAS OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    DURING A TREATMENT PROCEDURE, A SHAFT 'FRACTURE' OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED MODERATELY CALCIFIED LESION. THIS 32X2.50 OMEGA STENT DELIVERY SYSTEM (SDS) WAS SELECTED; HOWEVER, DURING POSITIONING OF THE SDS THE SHAFT 'RUPTURED' DURING ENTRY INTO THE INTRODUCER, DUE TO DEFORMATION WHEN AXIAL FORCE WAS APPLIED. IT WAS FURTHER REPORTED THAT THE SDS WAS ABLE TO BE POSITIONED BUT THE MATERIAL FATIGUE DUE TO THE REITERATED DEFORMATION LEAD TO THE RUPTURE, IMMEDIATELY BEFORE INFLATING THE BALLOON. THE DEVICE WAS SUCCESSFULLY REMOVED WITHOUT ANY COMPLICATIONS. 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.

    Description of Event or Problem · 1

    DURING A TREATMENT PROCEDURE, A SHAFT "FRACTURE" OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED MODERATELY CALCIFIED LESION. THIS 32X2.50 OMEGA STENT DELIVERY SYSTEM (SDS) WAS SELECTED; HOWEVER, DURING POSITIONING OF THE SDS THE SHAFT "RUPTURED" DURING ENTRY INTO THE INTRODUCER, DUE TO DEFORMATION WHEN AXIAL FORCE WAS APPLIED. IT WAS FURTHER REPORTED THAT THE SDS WAS ABLE TO BE POSITIONED BUT THE MATERIAL FATIGUE DUE TO THE REITERATED DEFORMATION LEAD TO THE RUPTURE, IMMEDIATELY BEFORE INFLATING THE BALLOON. THE DEVICE WAS SUCCESSFULLY REMOVED WITHOUT ANY COMPLICATIONS. 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
    87439 OMEGA¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913832250 15685292

    Patients

    Seq Age Sex Outcome Treatment
    1