BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET XL 360 SOFT 6MM X 20CM

    MDR report key: 6117085 · Received November 21, 2016

    Report

    Report Number
    3008881809-2016-00269
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 26, 2016
    Report Date
    February 6, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    07613327004625
    PMA / PMN Number
    K123377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. INFORMATION AVAILABLE INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE. ADDITIONALLY, THE EVENT DESCRIPTION INDICATED THAT THE MICROCATHETER (TERUMO (ID: 0.021INCH)) WAS USED IN THE PROCEDURE WHICH ACCORDING TO THE DEVICE DIRECTIONS FOR USE (DFU) WAS NOT RECOMMENDED FOR THIS DEVICE. THE TARGET DFU STATES "TARGET DETACHABLE COILS ARE COMPATIBLE WITH STRYKER NEUROVASCULAR 2-TIP MARKER MICROCATHETER¿S (MIN. INTERNAL DIAMETER 0.41 MM [0.016 IN], MAX. INTERNAL DIAMETER 0.48 MM [0.019 IN])". INFORMATION FROM THE COMPLAINT INDICATED THAT INSUFFICIENT FLUSH WAS USED DURING THE PROCEDURE WHICH WAS ALSO AGAINST THE DFU WHICH STATES "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". BASED ON THE INFORMATION CURRENTLY AVAILABLE, A CAUSE OF USE ERROR WAS ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS IS 1 OF 2 REPORTS FILED FOR EACH OF THE COILS THAT DETACHED MECHANICALLY. THE SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPOSITIONING OF THE COILS IN THE ANEURYSM, EACH DETACH MECHANICALLY AT THE DETACHMENT ZONE. EACH OF THE COILS WAS RESPECTIVEY REMOVED TOGETHER WITH THE MICROCATHETER EVERY TIME WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REPOSITIONING OF THE COILS IN THE ANEURYSM, EACH DETACH MECHANICALLY AT THE DETACHMENT ZONE. EACH OF THE COILS WAS RESPECTIVELY REMOVED TOGETHER WITH THE MICROCATHETER EVERY TIME WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768645 TARGET XL 360 SOFT 6MM X 20CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 19067092 07613327004625

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER (TERUMO)