BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAPAQ - PLATINUM MICROCOIL

    MDR report key: 5029690 · Received August 25, 2015

    Report

    Report Number
    1226348-2015-00021
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 4, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K080379
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE HOSPITAL CONTACT THAT THE DELTAPAQ (DFS10015420/P10133) DID NOT DETACH, DETACHED DURING WITHDRAWAL, AND STRETCHED. TWO COILS WERE USED DURING THE SAME PROCEDURE. THE 1ST ONE (DFS 100304-20/C10824) WAS DEPLOYED WITHOUT DIFFICULTY. HOWEVER, THE 2ND COIL DID NOT DETACH COMPLETELY OF THE MICROCATHETER (DETAILS UNKNOWN). THE DISTAL PART OF THE COIL WAS ALWAYS ATTACHED TO ITS PUSHER. WHEN THE SURGEON TRIED TO REMOVE THE COIL IT DEPLOYED BY ITSELF. THE SURGEON TRIED TO RETRIEVE IT THANKS TO A LASSO (DETAILS UNKNOWN) WITHOUT SUCCESS BECAUSE THE 2 COILS WERE INTERLOCKED. FINALLY THE COIL STRETCHED, LEADING TO A HEPARIN TREATMENT. THE PATIENT WOKE UP CORRECTLY UNFORTUNATELY A BLEEDING APPEARED TWICE 8 HOURS AFTER SURGERY LEADING TO A DETERIORATION IN HER CLINICAL STATE. THE PATIENT WAS FEMALE AND (B)(6). THE COILS REMAIN IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE. THE TARGET VESSEL WAS ANTERIOR COMMUNICATING ARTERY WHICH WAS NOT TORTUOUS. BASED ON THE INFORMATION, THE EVENT WAS NOT CONFIRMED. THE DELTAOAQ (DFS10015420, LOT P10133) WILL NOT BE RETURNED, THEREFORE THE ROOT CAUSE OF THE COILS ENTANGLEMENT, FAILURE TO DETACH, AND ITS PREMATURE DETACHMENT CANNOT BE DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: COIL (DFS 100304-20/C10824). MICROCATHETER (DETAILS UNKNOWN). LASSO (DETAILS UNKNOWN). THIS IS 1 OF 2 REPORTS ASSOCIATED WITH REPORT 1226348-2015-00020.

    Additional Manufacturer Narrative · 1

    CONCLUSION UPDATED WITH ADDITIONAL INFORMATION: IT WAS REPORTED BY THE HOSPITAL CONTACT THAT THE DELTAPAQ (DFS10015420/P10133) DID NOT DETACH, DETACHED DURING WITHDRAWAL, AND STRETCHED. TWO COILS WERE USED DURING THE SAME PROCEDURE. THE 1ST ONE (DFS 100304-20/C10824) WAS DEPLOYED WITHOUT DIFFICULTY. HOWEVER, THE 2ND COIL DID NOT DETACH COMPLETELY OF THE MICROCATHETER (DETAILS UNKNOWN). THE DISTAL PART OF THE COIL WAS ALWAYS ATTACHED TO ITS PUSHER. WHEN THE SURGEON TRIED TO REMOVE THE COIL IT DEPLOYED BY ITSELF. THE SURGEON TRIED TO RETRIEVE IT THANKS TO A LASSO (DETAILS UNKNOWN) WITHOUT SUCCESS BECAUSE THE 2 COILS WERE INTERLOCKED. FINALLY THE COIL STRETCHED, LEADING TO A HEPARIN TREATMENT. THE PATIENT WOKE UP CORRECTLY UNFORTUNATELY A BLEEDING APPEARED TWICE 8 HOURS AFTER SURGERY LEADING TO A DETERIORATION IN HER CLINICAL STATE. THE PATIENT WAS FEMALE AND 50 YEARS OLD. THE COILS REMAIN IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. THE LOW BATTERY LIGHT AND FAULT LIGHT WERE NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE. THE TARGET VESSEL WAS ANTERIOR COMMUNICATING ARTERY WHICH WAS NOT TORTUOUS. THE DELTAPAQ (DFS10015420, LOT P10133) WILL NOT BE RETURNED, THEREFORE THE ROOT CAUSE OF THE COILS ENTANGLEMENT, FAILURE TO DETACH, AND ITS PREMATURE DETACHMENT CANNOT BE DETERMINED. DHR: A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. FAILURE TO DETACH, PREMATURE DETACHMENT, ENTANGLEMENT AND UNRAVELED/STRETCHED ARE KNOWN POSSIBLE PRODUCT MALFUNCTIONS ASSOCIATED WITH THE USE OF EMBOLIZATION COILS. NEUROLOGIC DETERIORATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH TREATMENT OF INTRACRANIAL ANEURYSMS. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT DEVICE INTERACTION, TARGET ANATOMY, DEVICE MANIPULATION, PATIENT CHARACTERISTICS AND MEDICAL REGIMEN ISSUES MAY HAVE ALL CONTRIBUTED TO THE REPORTED EVENTS. THIS IS 1 OF 2 REPORTS ASSOCIATED WITH REPORT 1226348-2015-00020.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL CONTACT THAT THE DELTAPAQ (DFS10015420/P10133) DID NOT DETACH, DETACHED DURING WITHDRAWAL, AND STRETCHED. TWO COILS WERE USED DURING THE SAME PROCEDURE. THE 1ST ONE (DFS 100304-20/C10824) WAS DEPLOYED WITHOUT DIFFICULTY. HOWEVER, THE 2ND COIL DID NOT DETACH COMPLETELY OF THE MICROCATHETER (DETAILS UNKNOWN). THE DISTAL PART OF THE COIL WAS ALWAYS ATTACHED TO ITS PUSHER. WHEN THE SURGEON TRIED TO REMOVE THE COIL IT DEPLOYED BY ITSELF. THE SURGEON TRIED TO RETRIEVE IT THANKS TO A LASSO (DETAILS UNKNOWN) WITHOUT SUCCESS BECAUSE THE 2 COILS WERE INTERLOCKED. FINALLY THE COIL STRETCHED, LEADING TO A HEPARIN TREATMENT. THE PATIENT WOKE UP CORRECTLY UNFORTUNATELY A BLEEDING APPEARED TWICE 8 HOURS AFTER SURGERY LEADING TO A DETERIORATION IN HER CLINICAL STATE. THE PATIENT WAS FEMALE AND 50 YEARS OLD. THE COILS REMAIN IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562427 DELTAPAQ - PLATINUM MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC P10133

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR