BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.

    MDR report key: 1934843 · Received December 21, 2010

    Report

    Report Number
    2939204-2010-01173
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K931584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. THE PROCEDURE WAS STOPPED AFTER THE PHYSICIAN WAS UNABLE TO RETRIEVE THE FRAGMENT. THE FEMORAL SHEATH WAS LEFT IN PLACE AT THE END OF THE PROCEDURE, THE PATIENT WAS HEPARINIZED AND SENT TO THE ICU. AT SOME POINT IN THE ICU, THE SHEATH CAME OUT AND THE PATIENT LOST APPROXIMATELY 2 UNITS OF BLOOD RESULTING IN HYPOTENSION. THE HYPOTENSION AND THE SEVERE STENOSIS IN BOTH LEFT AND RIGHT INTERNAL CAROTID ARTERIES LED TO A STROKE THAT HAS NOT YET RESOLVED AS PER THE PHYSICIAN ON (B)(6)-2010. THE PHYSICIAN DID NOT ALLEGE THE STROKE WAS DUE TO THE UNRETRIEVED FRAGMENT.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS RETAINED BY THE FACILITY SO WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION IT WAS CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THE PHYSICIAN ENCOUNTERED DIFFICULTIES CROSSING THE STENOTIC LESION IN THE RIGHT CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). DURING THE ATTEMPT TO CROSS THE LESION, IT WAS REPORTED THAT THE TIP OF THE DEVICE BECAME STUCK. AS THE DEVICE WAS BEING RETRACTED, APPROXIMATELY 2CM OF THE DISTAL TIP BROKE OFF AND REMAINED IN THE LESION. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE FRAGMENT AND IT REMAINS IMPLANTED IN THE PATIENT. THE PATIENT DID NOT SUFFER ANY COMPLICATIONS DUE TO THE DEVICE BREAK OR THE UNRETRIEVED FRAGMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN ENCOUNTERED DIFFICULTIES CROSSING THE STENOTIC LESION IN THE RIGHT CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). DURING THE ATTEMPT TO CROSS THE LESION, IT WAS REPORTED THAT THE TIP OF THE DEVICE BECAME STUCK. AS THE DEVICE WAS BEING RETRACTED, APPROXIMATELY 2CM OF THE DISTAL TIP BROKE OFF AND REMAINED IN THE LESION. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE FRAGMENT AND IT REMAINS IMPLANTED IN THE PATIENT. THE PATIENT DID NOT SUFFER ANY COMPLICATIONS DUE TO THE DEVICE BREAK OR THE UNREPRIEVED FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS. WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001468060 13820372

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention