BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET XL 360 SOFT 4MM X 12CM

    MDR report key: 7539149 · Received May 23, 2018

    Report

    Report Number
    3008881809-2018-00239
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    May 1, 2018
    Report Date
    June 22, 2018
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    07613327128338
    PMA / PMN Number
    K153658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PHYSICAL AS WELL AS FUNCTIONAL TESTING COULD NOT BE PERFORMED. BASED ON THE ADDITIONAL INFORMATION PROVIDED IT IS MOST LIKELY THAT THE MAIN COIL BROKE DUE TO A LACK OF CONTINUOUS FLUSH DURING THE PROCEDURE. LACK OF CONTINUOUS FLUSH CAN RESULT IN FRICTION ISSUES CAUSING THE COIL TO BREAK. AS PER THE DEVICE DIRECTIONS FOR USE (DFU): "IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE OF THE TARGET DETACHABLE COIL SYSTEM AND TO REDUCE THE RISK OF THROMBOEMBOLIC COMPLICATIONS, IT IS CRITICAL THAT A CONTINUOUS INFUSION OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN THE FEMORAL SHEATH AND GUIDING CATHETER, THE 2-TIP MICROCATHETER AND GUIDING CATHETERS, AND THE 2-TIP MICROCATHETER AND STRYKER NEUROVASCULAR GUIDEWIRE AND DELIVERY WIRE. CONTINUOUS FLUSH ALSO REDUCES THE POTENTIAL FOR THROMBUS FORMATION ON, AND CRYSTALLIZATION OF INFUSATE AROUND, THE DETACHMENT ZONE OF THE TARGET DETACHABLE COIL". BECAUSE THE DEVICE DFU CONTAINS SPECIFIC INSTRUCTIONS REGARDING USE OF CONTINUOUS FLUSH, WHICH WAS OMITTED, AN ASSIGNABLE CAUSE OF USE ERROR WAS ASSIGNED FOR THE REPORTED EVENT. IN ADDITION, IT WAS REPORTED THAT THE TOP OF THE SHEATH WAS STRONGLY CRIMPED INTO THE HUB OF THE MICROCATHETER, AND ALSO, A NON-STRYKER MICROCATHETER WAS USED DURING THIS PROCEDURE WHICH MAY ALSO CONTRIBUTED TO THE REPORTED FAILURE DUE TO POTENTIAL INCOMPATIBILITY OF A NON-STRYKER DEVICE DUE TO THE POTENTIAL INCOMPATIBILITY OF NON-STRYKER NEUROVASCULAR DEVICES WITH THE TARGET DETACHABLE COIL SYSTEM, THE USE OF OTHER MANUFACTURER¿S DEVICE(S) WITH THE TARGET DETACHABLE COIL SYSTEM IS NOT RECOMMENDED AS PER DFU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN CRIMPED THE TIP OF THE SHEATH STRONGLY INTO THE HUB OF THE MICROCATHETER CAUSING THE SUBJECT COIL DISTAL TIP TO BREAK. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN CRIMPED THE TIP OF THE SHEATH STRONGLY INTO THE HUB OF THE MICROCATHETER CAUSING THE SUBJECT COIL DISTAL TIP TO BREAK. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381595 TARGET XL 360 SOFT 4MM X 12CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 19704796 07613327128338

    Patients

    Seq Age Sex Outcome Treatment
    1