BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTI-LENGTH COMFORT 4.6FX22-30CM

    MDR report key: 1172770 · Received September 18, 2008

    Report

    Report Number
    2027111-2008-00043
    Event Type
    Other
    Date Received
    September 18, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 18, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED STENT REVEALED SECTIONS THAT HAD BEEN CRUSHED, APPARENTLY DUE TO INADEQUATE PROTECTION DURING SHIPMENT FROM THE HOSPITAL. THE STENT HAD BEEN SHIPPED IN A SIMPLE MAILING ENVELOPE. LONGITUDINAL DISSECTION OF THE STENT REVEALED A CLEAR LUMEN. BASED ON INFORMATION FROM THE SALES REP, THE APPLIED STENT DID NOT ALLOW THE KIDNEY TO DRAIN AND WAS REPLACED BY A COOK STENT. THE RETURNED (APPLIED) STENT DID NOT PRESENT WITH ANY OBVIOUS ARTIFACTS SUGGESTING THAT IT HAD OCCLUDED. IT IS UNCLEAR WHETHER THE COOK STENT OR THE ACT OF REPLACING THE APPLIED STENT WAS RESPONSIBLE FOR RESTORING DRAINAGE. THEREFORE, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION RELATED TO THE CONDITIONS SURROUNDING THE EVENT. THIS CONCLUDES OUR EVALUATION. THIS REPORT REPRESENTS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    "CYSTO BILATERAL STENT PLACEMENT; UNEVENTFUL STENT PLACEMENT; BILATERAL." PATIENT REQUIRED BILATERAL PERCUTANEOUS DRAINAGE. PER A CONVERSATION WITH THE REP IN 2008, BILATERAL STENTS WERE PLACED AFTER LITHOTRIPSY, WITHIN TWO DAYS THE PATIENT RETURNED IN A LOT OF PAIN. THE APPLIED STENTS WERE REMOVED AND REPLACED WITH A COOK STENT. PRODUCT WAS SHIPPED BY HOSPITAL IN AN ENVELOPE THROUGH THE MAIL RESULTING IN CRUSHING OF THE STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LENGTH COMFORT 4.6FX22-30CM NONE FAD APPLIED MEDICAL RESOURCES B3827 1063757

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention