BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 2884632 · Received December 23, 2012

    Report

    Report Number
    2954740-2012-00830
    Event Type
    Malfunction
    Date Received
    December 23, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION OF TYPE II ENDOLEAK THAT ORIGINATED FROM INTERNAL ILIAC ARTERY TO DISTAL BRANCHES. THE CHARACTERISTIC OF THE VESSEL WAS MODERATELY CALCIFIED AND HEAVILY TORTUOUS. ACCESS WAS OBTAINED FROM FEMORAL ARTERY. DURING THE PROCEDURE, WHILE ADVANCING A DELTAPAQ ((B)(4), COMPLAINT PRODUCT) IN AN UNSPECIFIED PROGREAT (TERUMO, TYPE UNKNOWN), THERE WAS SEVERE RESISTANCE AROUND 20 CM FROM THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN COULD NOT PUSH THE COIL ANY FURTHER. THEREFORE, BOTH THE DELTAPAQ AND THE MICROCATHETER WERE SAFELY REMOVED FROM THE PATIENT AS A UNIT. THE PROCEDURE WAS CONTINUED USING A NEW DELTAPAQ (LOT UNKNOWN) AND A NEW UNSPECIFIED MICROCATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. PRIOR TO THE COMPLAINT PRODUCT, ONE DELTAPAQ ((B)(4), LOT UNKNOWN) WAS PLACED IN THE TARGET LESION WITHOUT ANY FURTHER ISSUES. IT IS 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 DEVICES AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE TARGET LESION OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C11427

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PROGREAT TERUMO MICROCATHETER