BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 6878633 · Received September 20, 2017

    Report

    Report Number
    2032582-2017-00002
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    July 10, 2017
    Report Date
    August 15, 2017
    Manufacturer
    PFM MEDICAL INC.
    Product Code
    LJT
    UDI-DI
    H965451810
    PMA / PMN Number
    K071993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORD: THE QUALITY RECORDS FOR THE LOT 135308000 ARE COMPLETE AND IN ORDER. NO NON-CONFORMITY WAS RECORDED FOR THIS LOT NUMBER. NO SIMILAR COMPLAINT HAS BEEN RECORDED FOR THIS LOT. NO DEVIATION HAS BEEN RECORDED IN MATERIAL AND/OR MANUFACTURING PROCESS DURING MANUFACTURING OF THE LOT NUMBER 135308000. RETURNED PRODUCT INVESTIGATION. IT WAS OBSERVED THAT THE CATHETER WAS DEFORMED ON A 1CM SECTION AT 7.5CM FROM THE TIP. A 5MM SLOT ON THE CATHETER SHOWS THAT THE SUBJECT CATHETER HAS BEEN CLAMPED AND DECLAMPED MANY TIMES. PINCH OFF GRADE 3 IS SUSPECTED. THE X-RAY IMAGE WAS NOT AVAILABLE TO CONFIRM THE CATHETER POSITION. ACCORDING TO THE PUNCTURE MARKS OBSERVED ON THE SEPTUM, THE PORT HAS LIKELY BEEN IMPLANTED FOR A FEW MONTHS. BASED ON THE SUBSTANTIAL TIME OF IMPLANTATION AND BASED ON OBSERVATION OF THE RETURNED PRODUCT, IT CAN BE CONCLUDED THAT THE LEAKAGE COMES FROM THE FRACTURE OF THE CATHETER AND SUCH FRACTURE IS DUE TO A PINCH-OFF GRADE 3: CATHETER DAMAGE. EXPLANATION: BASED ON THE INFORMATION PROVIDED IT IS SUPPOSED THAT THE CATHETER, INSERTED INTO THE SUBCLAVIAN, WAS COMPRESSED BETWEEN THE FIRST RIB AND THE CLAVICAL. SUCH EFFECT IS VERY WELL DESCRIBED IN LITERATURE AND IN THE INSTRUCTIONS FOR USE. IT IS NAMED "PINCH-OFF". THE RECOMMENDED ACTION FOR A GRADE 3 PINCH-OFF IS THE PROMPT REMOVAL OF THE CATHETER, WHICH WAS FOLLOWED BY THE HEALTHCARE PROFESSIONAL. REVIEW OF RISK ANALYSIS: THE RISK OF "CATHETER FRACTURE" IS IDENTIFIED IN THE RISK ANALYSIS (PER ISO 14971) AND EVALUATED WITH AN OCCURENCE OF < 0.005%. A REVIEW OF COMPLAINTS SHOWED THAT THE MOST FREQUENT CAUSE OF A CATHETER FRACTURE IS A PINCH-OFF GRADE 3. THE REVIEW OF THE INSTRUCTIONS FOR USE SHOWS DETAILED/ADEQUATE INSTRUCTION FOR PORT CATHETER PLACEMENT AND PINCH OFF WARNING. CONCLUSION: BASED ON THE INVESTIGATION OF THE RETURNED PRODUCT, THE REPORTED PROBLEM IS BEING ATTRIBUTES TO A PINCH-OFF GRADE 3. THE MOST FREQUENT CAUSE OF A CATHETER FRACTURE IN PINCH-OFF GRADE 3. THIS RISK IS IDENTIFIED IN THE RISK ANALYSIS AND SUCH CAUSE IS VERY WELL DESCRIBED IN THE LITERATURE AND IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    PORT LEAKED IN PATIENT - ACCESSED ON SIDE OF PORT AND PATIENT IMMEDIATELY BRUISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659143 XCELA PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT PFM MEDICAL INC. H965451810 135308000 H965451810

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention