BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CES MICROCATHETERS (KRA)

    MDR report key: 1480812 · Received July 14, 2009

    Report

    Report Number
    1058196-2009-00150
    Event Type
    Malfunction
    Date Received
    July 14, 2009
    Date of Event
    June 13, 2009
    Report Date
    June 18, 2009
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL THE PRODUCTS WERE NEW, AND ALL THE PRODUCTS WERE PREP PER (IFU) INSTRUCTION FOR USE. THE SUER WAS TRAINED TO USE THE DEVICE. A CONSTANT AND DEDICATED FLUSH WAS MAINTAINED AT ALL TIMES THROUGH THE MICROCATHETER. THE MICROCATHETER WAS NOT RE-SHAPED. DURING DELIVERY, THE MICROCATHETER WAS PASSED DISTAL TO THE ANEURYSM NECK, AND THEN THE MICROCATHETER WAS WITHDRAWN SLOWLY WHILE PINNING/MAINTAINING THE ENTERPRISE DELIVERY SYSTEM IN PLACE. DURING STENT DETACHMENT, CONSTANT FLUOROSCOPY WAS CONDUCTED. HOWEVER, THE STENT DID NOT RELEASE. CONTROL WAS NOT LOST WITH THE ENTERPRISE SYSTEM OR MICROCATHETER, BUT THE STENT HAD PASSED THE POINT OF RECAPTURABILITY. CONSTANT FLUOROSCOPY WAS PERFORMED DURING DEPLOYMENT AND RECAPTURING OF THE STENT. AFTER REMOVAL FROM THE PT, NO DAMAGES WERE NOTED ON THE ENTERPRISE STENT OR MICROCATHETER. THE STENT WAS NOT OUTSIDE THE MICROCATHETER. NO FURTHER INFO WAS AVAILABLE. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PARENT ARTERY WAS 3.3 CM TUMOR DIAMETER WAS 2.5 CM, NECK SIZE WAS 2.5 AND 3 PROXIMALLY. DURING THE PROCEDURE, THE PHYSICIAN WITHDREW (MC) MICROCATHETER (CATALOG AND LOT NUMBER UNK) READY TO DEPLOY THE STENT, BUT FOUND THAT THE ENTERPRISE STENT WAS REMOVED TOGETHER WITH THE MC. THEN THE MC AND ENTERPRISE STENT WERE REMOVED AS A UNIT FROM THE PT, AND ANOTHER MC AND ENTERPRISE STENT WERE UTILIZED TO COMPLETE THE PROCEDURE. BOTH THE MC AND STENT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CES MICROCATHETERS (KRA) KRA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR ENTERPRISE VRD| DELIVERY