BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT CT

    MDR report key: 20925201 · Received December 13, 2024

    Report

    Report Number
    1317056-2024-00254
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    January 14, 2015
    Report Date
    April 29, 2025
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    H787CT96STSD0
    PMA / PMN Number
    K062414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF CATHETER TUBING BECAME FRACTURED/LEAKED CANNOT BE CONFIRMED. NO PORT/CATHETER TUBING DEVICE WAS RETURNED FOR EVALUATION. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. DEVICE HISTORY RECORD REVIEW OF THE PACKAGING/ASSEMBLY/CATHETER LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) THAT IS SUPPLIED WITH THIS PORT DEVICE, CONTAINS THE FOLLOWING STATEMENTS: - ABSENCE OF A BLOOD RETURN OR A POOR BLOOD RETURN CAN BE A SIGN OF A POTENTIAL COMPLICATION SUCH AS OCCLUSION, KINKING, BREAKAGE, PINCH-OFF SYNDROME, FIBRIN FORMATION, THROMBOSIS OR MALPOSITION. THIS SHOULD BE EVALUATED PRIOR TO DEVICE USAGE. A BLOOD RETURN SHOULD BE PRESENT PRIOR TO USAGE OF DEVICE FOR ANY THERAPY OR TESTING. - IF THE PATIENT COMPLAINS OF PAIN, OR IF THERE IS SWELLING WHEN THE DEVICE IS FLUSHED OR WHEN MEDICATION OR CONTRAST MEDIA IS ADMINISTERED, EVALUATE THE DEVICE FOR INFILTRATION, PROPER NEEDLE PLACEMENT, AND POTENTIAL COMPLICATIONS SUCH AS OCCLUSION, KINKING, BREAKAGE, PINCH-OFF SYNDROME, THROMBOSIS OR MALPOSITION. FAILURE TO ASSESS THESE COMPLAINTS OR OBSERVATIONS CAN LEAD TO DEVICE FAILURE. CAUTION: AVOID PIERCING CATHETER WITH SUTURE NEEDLE. POTENTIAL COMPLICATIONS: - CATHETER DISCONNECTION OR MIGRATION - CATHETER FRAGMENTATION - CATHETER PINCH-OFF - DRUG EXTRAVASATION (LEAKAGE) - EROSION OF VESSEL AND SKIN - INFLAMMATION CATHETER PLACEMENT CONSIDERATIONS: WARNING: AVOID MEDIAL CATHETER PLACEMENT INTO SUBCLAVIAN VEIN THROUGH PERCUTANEOUS TECHNIQUE. THIS PLACEMENT COULD LEAD TO CATHETER OCCLUSION, DAMAGE, RUPTURE, SHEARING, OR FRAGMENTATION DUE TO COMPRESSION OF THE CATHETER BETWEEN THE FIRST RIB AND CLAVICLE. CATHETER SHEARING HAS BEEN REPORTED WHEN THE CATHETER IS INSERTED VIA A MORE MEDIAL ROUTE IN THE SUBCLAVIAN VEIN. PINCH-OFF SYNDROME: PINCH-OFF SYNDROME SIGNS MAY INCLUDE DIFFICULTY IN ASPIRATING BLOOD, RESISTANCE TO FLUSHING OR INFUSION OF MEDICATIONS OR FLUIDS THAT IMPROVES WITH POSITION CHANGES, INFRACLAVICULAR PAIN AND/OR SWELLING WITH CATHETER FLUSHING OR INFUSION PALPITATIONS, SUDDEN ONSET CHEST PAIN, CARDIAC ARRHYTHMIAS, EXTRA HEART SOUND, CHEST WALL SWELLING AT THE PORT POCKET, VEIN INSERTION SITE, PAIN IN SHOULDER OR PORT AREA NOT ASSOCIATED WITH SWELLING, COUGH, PARESTHESIA OF ARM ON SIDE OF CATHETER WITHDRAWAL OCCLUSION OR SWISHING SOUND WITH CATHETER FLUSHING. WARNING: AVOID MEDIAL CATHETER PLACEMENT INTO SUBCLAVIAN VEIN THROUGH PERCUTANEOUS TECHNIQUE. THIS PLACEMENT COULD LEAD TO CATHETER OCCLUSION, DAMAGE, RUPTURE, SHEARING, OR FRAGMENTATION DUE TO COMPRESSION OF THE CATHETER BETWEEN THE FIRST RIB AND CLAVICLE. CATHETER SHEARING HAS BEEN REPORTED WHEN THE CATHETER IS INSERTED VIA A MORE MEDIAL ROUTE IN THE SUBCLAVIAN VEIN. NOTE: IF INFUSION OR ASPIRATION IS SUCCESSFUL UPON LIFTING ARM ABOVE THE HEAD AND TURNING THE HEAD, CONSIDER PINCH-OFF SYNDROME AS A POSSIBLE CAUSE. THE LINE SHOULD BE RADIOLOGICALLY EVALUATED IF PINCH-OFF SYNDROME IS SUSPECTED. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT CONTINUES TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2014, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, MODEL NUMBER: CT96STSD AND LOT NUMBER: 4790165. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., (B)(6) HOSPITAL (B)(6), TO FACILITATE FREQUENT IV ACCESS. ON OR ABOUT (B)(6) 2015, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER (B)(6), FOR A PORT CHECK. THE CHECK REVEALED THAT THE CATHETER HAD FRACTURED AND WAS LEAKING NEAR PLAINTIFF'S UPPER RIGHT NECK. ON OR ABOUT (B)(6) 2015, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER (B)(6) FOR PORT REMOVAL. THE DEFECTIVE PORT WAS REMOVED BY DR. (B)(6), M.D. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE CORRECTIVE SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES, AND PRESENT AND FUTURE LOST WAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414643 SMART PORT CT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC CT96STSD 4790165 H787CT96STSD0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female