BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETACHABLE AZUR PERIPHERAL COIL SYSTEM (AZUR)

    MDR report key: 3131098 · Received May 23, 2013

    Report

    Report Number
    2032493-2013-00030
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THE COIL DETACHED FROM THE DELIVERY PUSHER. THE DELIVER PUSHER WAS NOT RETURNED FOR EVALUATION. THE COIL IS STRETCHED AT THE PROXIMAL END. THE IMPLANT GEL APPEARS PARTIALLY SWOLLEN. NO EVIDENCE OF SWELLING IS PRESENT AT THE MID OR DISTAL PORTIONS OF THE IMPLANT PATIENT. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. IT IS NOT KNOWN IF THE STRETCHED PORTION OCCURRED DUE TO RESISTANCE DURING THE REPOSITIONING OR AS A RESULT OF SNARING. THE CATHETER USED WITH THIS DEVICE WAS NOT RETURNED FOR EVALUATION. WE CANNOT DETERMINE IF THIS WAS A CONTRIBUTING FACTOR. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON POSITIONING AN EMBOLIZATION COIL WITHIN A VESSEL, THE COIL WAS IN THE WRONG POSITION. ATTEMPTS WERE MADE TO REPOSITION TO DESIRED POSITION UNSUCCESSFULLY. THE COIL PREMATURELY DETACHED AND REMAINED IN THE ARTERY. A SNARE LASSO WAS USED TO RETRIEVED THE COIL SUCCESSFULLY. NO HARM OR INJURY WAS REPORTED. PATIENT INFORMATION: PATIENT IDENTIFIER, AGE, SEX, AND WEIGHT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227981 DETACHABLE AZUR PERIPHERAL COIL SYSTEM (AZUR) EMBOLIZATION COIL HCG MICROVENTION, INC. 45-480620 12112606

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R