BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPORT ISP MRI 6CF INT W SP, ATT, SL

    MDR report key: 21838795 · Received April 15, 2025

    Report

    Report Number
    3006260740-2025-02330
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 13, 2025
    Report Date
    September 3, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJT
    PMA / PMN Number
    K063377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. THREE PHOTOS WERE PROVIDED FOR REVIEW. THE FIRST PHOTO SHOWS THE PARTIAL VIEW OF A GUIDEWIRE PLACED ON A WHITE SURFACE. THE SECOND PHOTO SHOWS A GUIDEWIRE PLACED ON A SURFACE BEING HELD BY A CLINICIAN. IN BOTH THE PHOTOS, UNCOILING CAN BE NOTED THROUGHOUT THE DISTAL PORTION OF THE GUIDEWIRE, AND THE CORE WIRES ARE NOTED TO BE PROTRUDING. DEFORMATION CAN BE NOTED IN THE CENTRE, AND THE J-TIP IS NOTED TO BE BROKEN. THE THIRD PHOTO SHOWS THE PRODUCT LABEL THAT CONTAINS PRODUCT DETAILS THAT MATCH WITH TW DATA (MATERIAL# 8806060 AND LOT# REJS5141). THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED FRACTURE AND IDENTIFIED STRETCHED, UNRAVELED, MATERIAL SEPARATION AND DEFORMATION ISSUES. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED ENTRAPMENT ISSUE AS THE EXACT CIRCUMSTANCE AT THE TIME OF THE REPORTED EVENT WAS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. G2, G3, H6 (DEVICE, METHOD, RESULT, CONCLUSION). SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PORT PLACEMENT PROCEDURE THE PORT GUIDEWIRE ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT GUIDEWIRE WAS STUCK INSIDE THE PATIENT'S VEIN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A PATIENT UNDERWENT FOR A PORT PLACEMENT PROCEDURE USING POWERPORT ISP MRI 6CF INT W SP, ATT, SL. DURING THE PROCEDURE THE PORT GUIDEWIRE ALLEGEDLY FRACTURED. IT WAS FURTHER REPORTED THAT GUIDEWIRE WAS STUCK INSIDE THE PATIENT'S VEIN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107230 POWERPORT ISP MRI 6CF INT W SP, ATT, SL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD, INC. (BASD) -3006260740 REJS5141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown