BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER TRIPLE LUMEN ACUTE DIALYSIS FULL PROCEDURAL TRAY STRAIGHT

    MDR report key: 2031995 · Received January 13, 2011

    Report

    Report Number
    3006260740-2011-00014
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    July 21, 2010
    Report Date
    January 11, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJT
    PMA / PMN Number
    K083675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. ADD'L INFO FROM USER FACILITY REPORT: (B)(4).

    Description of Event or Problem · 1

    A RESIDENT PHYSICIAN ATTEMPTED TO PLACE A DIALYSIS CATHETER FOR INITIATION OF CONTINUOUS RENAL REPLACEMENT THERAPY FOR METABOLIC AND VOLUME CLEARANCE. THE RESIDENT PHYSICIAN ENCOUNTERED RESISTANCE WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE, BUT WHEN RETRIEVED, THE CATHETER TIP APPEARED INTACT. A "METALLIC FOREIGN BODY" WAS IDENTIFIED ON A CXR TAKEN ON (B)(6) 2010. THE PT WAS TAKEN TO IVR IN AN ATTEMPT TO RETRIEVE THE RETAINED CATHETER. THE INTERVENTIONAL ATTEMPT WAS UNSUCCESSFUL AS THE RETAINED PIECE WAS LOCATED IN THE DISTAL PULMONARY ARTERY. UPON FURTHER REVIEW, THE ACTUAL CATHETER AND NOT THE GUIDEWIRE WAS BELIEVED TO HAVE SHREDDED. ADD'L INFO FROM USER FACILITY REPORT: ON (B)(6) 2010, A RESIDENT PHYSICIAN ATTEMPTED TO PLACE A DIALYSIS CATHETER FOR INITIATION OF CONTINUOUS RENAL REPLACEMENT THERAPY FOR METABOLIC AND VOLUME CLEARANCE. THE RESIDENT PHYSICIAN ENCOUNTERED RESISTANCE WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE, BUT WHEN RETRIEVED, THE CATHETER TIP APPEARED INTACT. A "METALLIC FOREIGN BODY" WAS IDENTIFIED ON A CHEST X-RAY TAKEN ON (B)(6) 2010. THE PT WAS TAKEN TO INTERVENTIONAL RADIOLOGY IN AN ATTEMPT TO RETRIEVE THE RETAINED CATHETER. THE INTERVENTIONAL ATTEMPT WAS UNSUCCESSFUL AS THE RETAINED PIECE WAS LOCATED IN THE DISTAL PULMONARY ARTERY. UPON FURTHER REVIEW, THE ACTUAL CATHETER AND NOT THE GUIDEWIRE WAS BELIEVED TO HAVE SHREDDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER TRIPLE LUMEN ACUTE DIALYSIS FULL PROCEDURAL TRAY STRAIGHT DIALYSIS CATHETER LJT C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention