BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F7 SKATER NEPHROSTOMY 35 CM

    MDR report key: 2413207 · Received January 9, 2012

    Report

    Report Number
    9613246-2012-00001
    Event Type
    Injury
    Date Received
    January 9, 2012
    Date of Event
    November 15, 2011
    Report Date
    January 6, 2012
    Manufacturer
    PBN MEDICALS DENMARK A/S
    Product Code
    FOZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER IN ORDER TO UNDERSTAND AND EVALUATE THE CIRCUMSTANCES DURING THE PROCEDURE. THE PRODUCTION DOCUMENTATION HAS BEEN REVIEWED, AND FOR THIS SPECIFIC LOT THERE IS NO INDICATION OF PROBLEMS DURING PRODUCTION. NO OTHER ISSUES HAVE BEEN REPORTED IN RELATION TO THIS SPECIFIC LOT (P362515), AND NO SIMILAR ISSUES HAVE BEEN REPORTED TO US IN THE PAST. BASED ON REVIEW OF THE RETURNED PRODUCT IT HAS NOT BEEN POSSIBLE TO VERIFY THE EXACT CAUSE OF THE CATHETER DAMAGES. WE ARE HOWEVER QUITE CONFIDENT THAT THE DAMAGES ARE A RESULT OF THE CATHETER BEING EXPOSED TO AN EXTERNAL FORCE, WHICH HAVE CAUSED SIGNIFICANT DAMAGE TO THE CATHETER.

    Description of Event or Problem · 1

    DURING REMOVAL OF A SKATER NEPHROSTOMY CATHETER, CUSTOMER STATES THAT THE DISTAL TIP OF THE CATHETER WAS CUT COMPLETELY AND BECAME LODGED IN THE PYELOCALICEAL CAVITY. ADDITIONAL INTERVENTIONAL PROCEDURE WAS REQUIRED TO REMOVE THE TIP OF THE DEVICE. IT IS UNK IF THE TIP WAS SHEARED BY THE GUIDE WIRE OR AS A RESULT OF A USER ERROR DURING THE REMOVAL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F7 SKATER NEPHROSTOMY 35 CM SKATER CATHETER FOZ PBN MEDICALS DENMARK A/S 755507035 P362515

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention