BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 PRE-SHAPED S 150CM

    MDR report key: 3082423 · Received April 29, 2013

    Report

    Report Number
    3008853977-2013-00133
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    DQY
    PMA / PMN Number
    K042568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 INSPECTION OF THE RETURNED DEVICE DID NOT FIND ANY ANOMALIES. THE HUB AND DISTAL SECTION OF THE CATHETER WAS INSPECTED UNDER A RAM OPTICAL SYSTEM AND NO ANOMALIES WERE NOTED. A 0.0158¿ MANDREL WAS INTRODUCED THROUGH THE CATHETER HUB AND ADVANCED OUT THE DISTAL WITHOUT ANY DIFFICULTIES. THE CATHETER WAS FLUSHED WITH WATER WITHOUT ANY DIFFICULTIES AND NO LEAKS FOUND DURING LEAKAGE TESTING. THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. BASED ON THE PERFORMED DEVICE INSPECTION, THE REPORTED EVENTS OF CATHETER SHAFT LEAK AND DIFFICULTIES TO FLUSH THE DEVICE WERE NOT CONFIRMED. THERE WERE NO ANOMALIES FOUND. THEREFORE, AN ASSIGNABLE CAUSE OF "NOT CONFIRMED" HAS BEEN ASSIGNED TO THE REPORTED EVENT.MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    DURING PREPARATION RESISTANCE WAS ENCOUNTERED WHILE THE CATHETER WAS BEING FLUSHED AND IT WAS FOUND THAT THE CATHETER LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING PREPARATION RESISTANCE WAS ENCOUNTERED WHILE THE CATHETER WAS BEING FLUSHED AND IT WAS FOUND THAT THE CATHETER LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183412 EXCELSIOR SL-10 PRE-SHAPED S 150CM CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR CORK 15613757

    Patients

    Seq Age Sex Outcome Treatment
    1