BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETERAL ACCESS SHEATH SET (UASS)

    MDR report key: 1983817 · Received February 10, 2011

    Report

    Report Number
    3005099803-2011-00181
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOD
    PMA / PMN Number
    K022135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT HAS BEEN RETAINED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A URETERAL ACCESS SHEATH SET, PACKAGED (5) PER BOX, WAS RECEIVED AT A MEDICAL CENTER. ACCORDING TO THE COMPLAINANT, WHILE UNPACKING THE BOX, IT WAS NOTED THAT THE UPN ON THE OUTSIDE OF THE BOX, DID NOT MATCH THE UPN OF THE INDIVIDUAL DEVICES WITHIN THE BOX. UPN (B)(4) LABELED ON THE OUTSIDE OF THE BOX WAS FOR URETERAL ACCESS SHEATH SIZE 11/13FR X 28CM. UPN (B)(4) LABELED ON THE INDIVIDUAL DEVICES WAS FOR URETERAL ACCESS SHEATH SIZE 11/13FR X 46CM. THERE WAS NO PATIENT INVOLVEMENT FOR THIS REPORTED EVENT. SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETERAL ACCESS SHEATH SET (UASS) CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC - MARLBOROUGH M0062502011

    Patients

    Seq Age Sex Outcome Treatment
    1