BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 2820973 · Received November 6, 2012

    Report

    Report Number
    2954740-2012-00770
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Removal / Correction Number
    1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    NOTE: WITH THE REVIEW OF ADDITIONAL INFORMATION THE POTENTIAL FOR INJURY ASSOCIATED WITH THE REPORTED EVENT IS REMOTE; THEREFORE, THIS DOES NOT MEET THE REQUIREMENTS FOR A REPORTABLE EVENT. ADDITIONALLY, NO FURTHER REPORTS WILL BE FORTHCOMING FOR THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION FOR INTERCOSTAL ARTERY. CHARACTERISTICS OF THE VESSEL WERE NOT PROVIDED. ACCESS WAS OBTAINED FROM THE FEMORAL ARTERY. THE EVENT HAPPENED DURING COIL INTRODUCTION. IT WAS NOTED THAT WHILE ADVANCING A DELTAPLUSH(CPL100206-30/G14679, COMPLAINT PRODUCT) IN AN UNSPECIFIED EXCELSIOR SL10, THERE WAS SEVERE RESISTANCE AROUND THE DISTAL SECTION OF THE MICROCATHETER. BOTH OF THE DELTAPLUSH AND THE UNSPECIFIED EXCELSIOR SL10 WERE SAFELY REMOVED AS A UNIT FROM THE PATIENT. THEN DELTAPLUSH WAS REPLACED FOR A NEW DELTAPLUSH (LOT UNKNOWN), WHICH WAS SUCCESSFULLY PLACED IN THE TARGET VESSEL USING THE SAME MICROCATHETER. PRIOR TO THE COMPLAINT PRODUCT, ONE COIL (DETAILS UNKNOWN) WAS PLACED IN THE TARGET LESION USING THE SAME MICROCATHETER WITHOUT ANY DIFFICULTIES. AFTERWARDS, THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES AND THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT WAS UNKNOWN HOW MANY COILS WERE SUCCESSFULLY PLACED AFTER THAT. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS, ETC), WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE ANEURYSM OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G14679

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN EXCELSIOR SL-10 MICROCATHETER