BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 150CM 2 TIP

    MDR report key: 4243445 · Received November 11, 2014

    Report

    Report Number
    3008853977-2014-00348
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 24, 2014
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    DQY
    PMA / PMN Number
    K013789
    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. VISUAL AND TACTILE INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE CATHETER WAS KINKED AT 8.0 CM FROM THE PROXIMAL END. THE CATHETER TIP WAS DAMAGED AND FRICTION WAS EXPERIENCED DURING A PATENCY TEST DUE TO THE DAMAGED TIP AND KINKED CATHETER. IT IS LIKELY THAT SOME PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITING THE PERFORMANCE OF THE DEVICE CONTRIBUTED TO THE OBSERVED ISSUES. HOWEVER, BOTH PROXIMAL AND DISTAL MARKER BANDS WERE PRESENT ON THE DEVICE AND ALL DIMENSIONS WERE WITHIN SPECIFICATION. THEREFORE, THE REPORTED EVENT OF THE RADIOPAQUE MARKER BANDS WERE MISSING WAS NOT CONFIRMED. MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    DURING THE PROCEDURE UNDER FLUORO THE PROXIMAL RADIOPAQUE MARKER WAS NOT VISIBLE ON THE CATHETER DISTAL TIP. THE DEVICE WAS UNEVENTFULLY REMOVED AND THERE WAS NO CONSEQUENCE TO THE PATIENT. IN THE PHYSICIAN¿S OPINION, THERE WAS "A POSSIBILITY THAT THE MARKER MIGHT BE HARD TO SEE BECAUSE THE TREATED AREA WAS POSTERIOR FOSSA".

    Description of Event or Problem · 1

    DURING THE PROCEDURE UNDER FLUORO THE PROXIMAL RADIOPAQUE MARKER WAS NOT VISIBLE ON THE CATHETER DISTAL TIP. THE DEVICE WAS UNEVENTFULLY REMOVED AND THERE WAS NO CONSEQUENCE TO THE PATIENT. IN THE PHYSICIAN¿S OPINION, THERE WAS "A POSSIBILITY THAT THE MARKER MIGHT BE HARD TO SEE BECAUSE THE TREATED AREA WAS POSTERIOR FOSSA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726315 EXCELSIOR SL-10 150CM 2 TIP CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR CORK 17878492

    Patients

    Seq Age Sex Outcome Treatment
    1