BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 6989840 · Received October 31, 2017

    Report

    Report Number
    3013875781-2017-00019
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 9, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE WAS NOT RETURNED AND NO ADDITIONAL INFORMATION COULD BE OBTAINED. DURING THE PROCEDURE, THE PRESIDIO 10 COIL (PC410041230/ LOT UNK) COULD NOT BE DETACHED. THE SURGEON TRIED TO WITHDRAW THE COIL. THE COIL DETACHED DURING WITHDRAWAL. A RING OF COIL PROTRUDED IN THE PARENT ARTERY. THE SURGEON DEPLOYED AN ENTERPRISE STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS; HOWEVER, THE DEVICES WAS NOT RETURNED AND NO ADDITIONAL INFORMATION COULD BE OBTAINED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT NUMBER OF THE AFFECTED PRODUCT WAS NOT PROVIDED, AND WITHOUT THE LOT NUMBER, MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED. THE COIL DETACHMENT, PREMATURE DETACHMENT AND PROTRUSION INTO THE PARENT VESSEL COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN FOR ANALYSIS. BASED ON THE MINIMAL INFORMATION PROVIDED, THE ROOT CAUSE OF THE EVENTS COULD NOT BE DETERMINED. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. THERE AR NO CURRENT SAFETY SIGNALS IDENTIFIED RELATED TO THE REPORTED EVENTS BASED ON REVIEW OF COMPLAINT HISTORIES FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UDI: LOT NUMBER UNKNOWN; (B)(4). MFG NAME CODMAN & SHURTLEFF, INC. DBA DEPUY SYNTHES PRODUCTS, INC. THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, PRESIDIO10 COIL (CATALOG PC410041230, LOT UNK) COULD NOT BE DETACHED. THE SURGEON TRIED TO WITHDRAW THE COIL. THE COIL DETACHED DURING WITHDRAWAL. A RING OF COIL PROTRUDED IN THE PARENT ARTERY. THE SURGEON DEPLOYED ENTERPRISE STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON THE PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769581 PRESIDIO 10 - CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention