BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERTORQUE 5F MARKER BAND FLUSH CATHETER

    MDR report key: 2110978 · Received June 2, 2011

    Report

    Report Number
    9616099-2011-00372
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K915836
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE EVENT IS NO LONGER CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING.

    Description of Event or Problem · 1

    THE MARKER BANDS WERE NOT MISSING. THEY WERE MOVED. THEY WERE NOTICED ON FLUORO NOT TO BE EVENLY SPACED. IT WAS THOUGHT TO BE THE PATIENT'S ANATOMY, BUT WHEN THE PRODUCT WAS REMOVED TO VERIFY, THEY SAW THAT THEY WERE MOVED. ANOTHER CATHETER WAS USED FOR THE PROCEDURE. THE CATHETER WAS NOT STRETCHED. THIS WAS AN ENDO CASE. THERE WAS NO DIFFERENT RESISTANCE THAN EVER BEFORE IN HIS CASES. THERE WERE NO PICTURES OF THE DEVICE TAKEN.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT DURING AN AORTIC ANEURYSM REPAIR - ENDOVASCULAR - WHEN THEY WERE DOING THE LEFT SIDE, WHICH WAS THE LAST SIDE, AS IT WAS TOWARDS THE END OF THE CASE, THEY DID AN ARTERIOGRAM AND NOTICED THAT THE MARKERS DID NOT SEEM TO BE EVENLY SPACED. THEY PULLED OUT THE PIG TAIL AND PULLED OUT ANOTHER ONE AND WHEN THEY LOOKED AT THEM NOTICED THAT 3 TO 5 (DOES NOT REMEMBER EXACTLY) HAD COME OFF. WHEN THEY DO THESE CASES, THEY PUT THE GRAFT NEAR THE RENAL ARTERY AND SHOOT AGAIN AND HE THINKS IT WAS AT THAT TIME THAT THEY PROBABLY DISLODGE, ALTHOUGH THEY DID NOT NOTICE THEY WERE SEPARATED AND HAVE MOVED OR MIGRATED, UNTIL THE LAST PART OF THE CASE. THE PHYSICIAN DID NOT FEEL LIKE THERE WAS ANY RESISTANCE OR FRICTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERTORQUE 5F MARKER BAND FLUSH CATHETER DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA 15307112

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R