BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 NANO 2 MM X 4 CM

    MDR report key: 7076512 · Received December 1, 2017

    Report

    Report Number
    3008881809-2017-00504
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 6, 2017
    Report Date
    January 23, 2018
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K113412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 MAIN COIL WAS PROTRUDING FROM A MICROCATHETER. IN ADDITION, IT WAS REVEALED THAT THE MAIN COIL WAS KINKED AND STRETCHED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. NO ANOMALIES WERE NOTED TO THE DEVICE PRIOR TO USE. THE ANATOMY WAS NOTED TO BE SEVERELY TORTUOUS WHICH IS LIKELY TO HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE IS LIKELY TO HAVE BEEN DAMAGED DURING USE RESULTING IN THE REPORTED COIL JAM. THE COMMUNICATION LOG INDICATES INTERMITTENT FLUSH WAS USED WHICH IS CONSISTENT WITH THE BLOOD NOTED IN THE MICROCATHETER DURING ANALYSIS. AS PER THE DFU "CAUTION: IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE OF STRYKER NEUROVASCULAR MICROCATHETERS AND TO MAINTAIN THE LUBRICITY OF THE HYDROLENE COATING SURFACE, IT IS CRITICAL THAT A CONTINUOUS FLOW OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN THE STRYKER NEUROVASCULAR MICROCATHETER AND GUIDE CATHETER, AND THE MICROCATHETER AND ANY INTRALUMINAL DEVICE. IN ADDITION, FLUSHING AIDS IN PREVENTING CONTRAST CRYSTAL FORMATION AND/OR CLOTTING ON BOTH THE INTRALUMINAL DEVICE AND INSIDE THE GUIDE CATHETER AND/OR THE MICROCATHETER LUMEN". THEREFOR AN ASSIGNABLE CAUSE OF USE ERROR WILL BE ASSIGNED TO THE MAIN COIL JAMMED, MAIN COIL MIGRATION, MAIN COIL KINKED/BENT AND MAIN COIL STRETCHED. AS THE INVESTIGATION CONFIRMS THAT THERE WAS AN ACT OR OMISSION OF AN ACT THAT RESULTED IN A DIFFERENT MEDICAL PRODUCT RESPONSE THAN INTENDED BY THE MANUFACTURER AND/OR EXPECTED BY THE USER.

    Description of Event or Problem · 1

    DURING THE TRANS-ARTERIAL EMBOLIZATION (TAE) PROCEDURE FOR RECTAL ARTERY, THE MAIN COIL OF THE SUBJECT DEVICE COULD NOT BE DETACHED AT THE FIRST ATTEMPT. THEREFORE THE MARKER WAS PROPERLY RE-ALIGNED AND THE COIL WAS DETACHED AT THE SECOND ATTEMPT. THEN DELIVERY WIRE WAS REMOVED. WHEN THE PHYSICIAN WAS TRYING TO REMOVE THE MICROCATHETER, IT WAS FOUND THAT THE MAIN COIL GOT STUCK IN THE TIP OF THE MICROCATHETER. SO THE PHYSICIAN TRIED TO PUSH THE MAIN COIL OUT WITH A GUIDEWIRE AND A COIL DELIVERY WIRE, BUT IT DID NOT WORK. ULTIMATELY, THE MAIN COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER AS ONE UNIT. THERE WERE NO ADVERSE CONSEQUENCE NOTED TO THE PATIENT.

    Description of Event or Problem · 1

    DURING THE TRANS-ARTERIAL EMBOLIZATION (TAE) PROCEDURE FOR RECTAL ARTERY, THE MAIN COIL OF THE SUBJECT DEVICE COULD NOT BE DETACHED AT THE FIRST ATTEMPT. THEREFORE THE MARKER WAS PROPERLY RE-ALIGNED AND THE COIL WAS DETACHED AT THE SECOND ATTEMPT. THEN DELIVERY WIRE WAS REMOVED. WHEN THE PHYSICIAN WAS TRYING TO REMOVE THE MICROCATHETER, IT WAS FOUND THAT THE MAIN COIL GOT STUCK IN THE TIP OF THE MICROCATHETER. SO THE PHYSICIAN TRIED TO PUSH THE MAIN COIL OUT WITH A GUIDEWIRE AND A COIL DELIVERY WIRE, BUT IT DID NOT WORK. ULTIMATELY, THE MAIN COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER AS ONE UNIT. THERE WERE NO ADVERSE CONSEQUENCE NOTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854138 TARGET 360 NANO 2 MM X 4 CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 19626950

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention XT-17 MICROCATHETER (STRYKER)