BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET HELICAL NANO 1MM X 1CM

    MDR report key: 8903930 · Received August 16, 2019

    Report

    Report Number
    3008881809-2019-00244
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 22, 2019
    Report Date
    October 31, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    04546540700216
    PMA / PMN Number
    K153658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE DELIVERY WIRE WAS KINKED AND FRACTURED. IN ADDITION, THE PROXIMAL CONTACT WAS FRACTURED AS WELL. A PROBABLE CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THE REPORTED AND ANALYZED DEFECTS ON THE DELIVERY WIRE AND PROXIMAL CONTACT, AS THE DEFECT APPEARS TO BE ASSOCIATED WITH HANDLING OF THE PRODUCT OR PORTION OF THE PRODUCT DURING THE PROCEDURE/UPON REMOVAL OF THE PRODUCT FROM THE PACKAGING/PREPARATION OF THE PRODUCT PRIOR TO USE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED DELIVERY WIRE WAS EXTREMELY KINKED BUT HAD NOT BROKEN. THEREFORE, THE REPORTED DELIVERY WIRE BROKEN WAS NOT CONFIRMED. EVEN THOUGH THE PROXIMAL CONTACT WIRE WAS FOUND BROKEN DURING THE ANALYSIS OF THE RETURNED DEVICE, THE PROXIMAL CONTACT IS NOT A CONTIGUOUS PART THAT FORMS THE DELIVERY WIRE, BUT IS A SUBCOMPONENT LOCATED AT THE PROXIMAL END OF THE DELIVERY WIRE THAT WORKS IN CONJUNCTION WITH THE INZONE DETACHMENT SYSTEM, AND IT REMAINS OUTSIDE THE PATIENT AT ALL TIMES DURING THE PROCEDURE. IT IS HIGHLY UNLIKELY THAT THE BROKEN PROXIMAL CONTACT MAY CONTRIBUTE TO AND/OR CAUSE ANY PATIENT INJURY. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE FOR THE ANEURYSM AT LEFT PCOMA (POSTERIOR COMMUNICATING ARTERY), THE PUSHER WIRE OF THE COIL WAS FRACTURED INSIDE THE PATIENT. SO THE PHYSICIAN WITHDRAW THE DEVICE AND FINISHED THE PROCEDURE. NO CLINICAL CONSEQUENCE REPORTED TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE FOR THE ANEURYSM AT LEFT PCOMA (POSTERIOR COMMUNICATING ARTERY), THE PUSHER WIRE OF THE COIL WAS FRACTURED INSIDE THE PATIENT. SO THE PHYSICIAN WITHDRAW THE DEVICE AND FINISHED THE PROCEDURE. NO CLINICAL CONSEQUENCE REPORTED TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EMBOLIZATION PROCEDURE FOR THE ANEURYSM AT LEFT PCOMA (POSTERIOR COMMUNICATING ARTERY), THE PUSHER WIRE OF THE COIL WAS FRACTURED INSIDE THE PATIENT. SO THE PHYSICIAN WITHDRAW THE DEVICE AND FINISHED THE PROCEDURE. NO CLINICAL CONSEQUENCE REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695280 TARGET HELICAL NANO 1MM X 1CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 20860454 04546540700216

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR SL-10 MICROCATHETER (STRYKER)