BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS / SMART PORT

    MDR report key: 6807605 · Received August 21, 2017

    Report

    Report Number
    1056436-2017-00099
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    August 1, 2017
    Report Date
    October 2, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    UDI-DI
    H787CT66LTPD0
    PMA / PMN Number
    K062414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: UPN CHANGED FROM (B)(4) TO UNKNOWN. ALSO 510K CHANGED FROM K062414 TO UNKNOWN. ALTHOUGH A DEVICE SAMPLE WAS RETURNED, THE PORT HAD NOT BEEN PURCHASED BY NOR IMPLANTED AT THE RETURNING HOSPITAL, SO EXACT UPN IDENTIFICATION WAS NOT POSSIBLE. NO DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED SINCE THERE WAS NO REPORTED LOT #. THE AUGUST 2017 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE SMARTPORT PRODUCT FAMILY AND THE FAILURE MODE "CATHETER FRACTURE. " NO ADVERSE TREND WAS IDENTIFIED. THE USED PORT WAS RECEIVED WITH A SECTION OF CATHETER TUBING ATTACHED AND THE COLLAR CONNECTED. THE PORT SEPTUM SHOWS MANY PUNCTURES. NO DAMAGE OR MANUFACTURING NON-CONFORMANCE OBSERVED DURING VISUAL INSPECTION OF THE PORT. THE CATHETER TUBING WAS ATTACHED TO THE PORT AT THE 22CM MARK; DISTAL TIP END OF THE CATHETER TUBING WAS AT 0CM MARK. A FRACTURE IN THE CATHETER TUBING WAS OBSERVED AT THE 19CM MARK (~4-5CM FROM PORT BODY). THIS FRACTURE IS JAGGED AND HAS APPEARANCE OF BEING A CRUSHING FLEX FAILURE (POTENTIAL PINCH-OFF FAILURE). THE CATHETER TUBING WAS CROSS-SECTIONED NEAR THE FRACTURE (~17CM MARK); CROSS-SECTIONED DID NOT SHOW ANY OUT-OF-ROUND OR THIN WALL ISSUES. DIMENSIONS OF THE CATHETER TUBING WERE TAKEN AT THIS LOCATION: ID AND OD WERE BOTH FOUND TO MEET SPECIFICATION. THE APPEARANCE OF THE FRACTURED END OF THE TUBING WAS JAGGED WITH TUBING CRUSHED, WHICH IS INDICATIVE OF A FLEX FAILURE. THIS TYPE OF CATHETER FRACTURE IS CONSISTENT WITH "PINCH-OFF SYNDROME" ALTHOUGH THE LOCATION WAS ONLY ~3.0 FROM THE PORT BODY (PINCH-OFF IS USUALLY OBSERVED BETWEEN 5-10CM FROM PORT BODY). DUE TO THE PORT BEING IN-SITU FOR AT LEAST 3 YEARS, FLEX FAILURE OF THE CATHETER TUBING IS POTENTIAL ROOT CAUSE. ANGIODYNAMICS PROCESS CONTROLS : PORT CATHETER TUBING-INSTRUCTS QUALITY INSPECTION PERSONNEL TO INSPECT FOR CATHETER MATERIAL, DISTAL TIP BOND, MARKINGS, STRIPE, CERTIFICATE OF MATERIAL/COMPLIANCE, OVERALL VISUAL, PARTICLES, ULTIMATE TENSILE FORCE AND OD/ID. THE DIRECTIONS FOR USE PROVIDED WITH THE SMARTPORT INCLUDE GUIDANCE ON PLACEMENT, PORT MAINTENANCE AND CAUTIONS INVOLVING THE POTENTIAL COMPLICATIONS OF CATHETER FRAGMENTATION AND CATHETER PINCH-OFF. ((B)(4)).

    Additional Manufacturer Narrative · 1

    IT HAS BEEN INDICATED THAT THE DEVICE FROM THE REPORTED EVENT WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION, BUT IT HAS NOT YET ARRIVED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, PORT/CATHETER HAD BEEN IMPLANTED IN PATIENT 3 YEARS PRIOR TO EVENT. DEVICE HAD BEEN USED FOR CHEMOTHERAPY. ON (B)(6) 2017 DIFFICULTY WAS ENCOUNTERED IN FLUSHING THE PORT, WHICH HAD NOT BEEN USED "FOR A BIT." THE PATIENT GOT A LARGE BUBBLE UNDER THE SKIN. THE PORT WAS REMOVED AND IT WAS INDICATED THAT THE CATHETER WAS "CRACKED." IT HAS BEEN STATED THAT THE USED CATHETER WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589135 ANGIODYNAMICS / SMART PORT PORT & CATHETER, IMPLANTED LJT ANGIODYNAMICS H787CT66LTPD0

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR