BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET 360 ULTRA 1.5 MM X 3 CM

    MDR report key: 3112250 · Received May 14, 2013

    Report

    Report Number
    3008853977-2013-00149
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 23, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 RETURNED PROTRUDING FROM THE DISTAL END OF THE MICROCATHETER (ECHELON 10, COVIDIEN). ALSO RETURNED WERE THE GT WIRE (TERUMO) AND GUIDE CATHETER (MANUFACTURER UNKNOWN). DRIED BLOOD WAS PRESENT ON THE COIL AND AT THE DISTAL TIP OF THE CATHETER. KINKS WERE NOTED ON THE DISTAL END OF THE COIL. THE DISTAL TIP OF THE COIL WAS INSPECTED AND NO ANOMALIES WERE NOTED. A PROBABLE CAUSE OF PROCEDURAL FACTORS HAS BEEN ASSIGNED TO THE EVENT AS IT IS LIKELY THAT PROCEDURAL FACTORS CAUSED THE PERFORMANCE OF THE DEVICE TO BE LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF A BASILAR ARTERY-TOP ANEURYSM, THE PHYSICIAN DEPLOYED 8 COILS INTO THE ANEURYSM. AFTER DETACHING THE 8TH COIL, THE PHYSICIAN REMOVED THE DELIVERY WIRE AND WAS PREPARING A 9TH COIL WHEN HE NOTED THAT THE TAIL OF THE 8TH COIL PROTRUDED INTO THE DISTAL END OF THE MICROCATHETER. HE "SANDWICHED" THE COIL BETWEEN THE GUIDEWIRE AND MICROCATHETER AND REMOVED THEM TOGETHER, ALONG WITH THE GUIDE CATHETER, FROM THE PATIENT. THE PATIENT IS REPORTED TO BE IN "GOOD" CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF A BASILAR ARTERY-TOP ANEURYSM, THE PHYSICIAN DEPLOYED 8 COILS INTO THE ANEURYSM. AFTER DETACHING THE 8TH COIL, THE PHYSICIAN REMOVED THE DELIVERY WIRE AND WAS PREPARING A 9TH COIL WHEN HE NOTED THAT THE TAIL OF THE 8TH COIL PROTRUDED INTO THE DISTAL END OF THE MICROCATHETER. HE ¿SANDWICHED¿ THE COIL BETWEEN THE GUIDEWIRE AND MICROCATHETER AND REMOVED THEM TOGETHER, ALONG WITH THE GUIDE CATHETER, FROM THE PATIENT. THE PATIENT IS REPORTED TO BE IN ¿GOOD¿ CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211773 TARGET 360 ULTRA 1.5 MM X 3 CM DEVICE NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 15680755R

    Patients

    Seq Age Sex Outcome Treatment
    1 ECHELON 10 MICROCATHETER (COVIDIEN)