BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GLIDEWIRE

    MDR report key: 1193305 · Received October 7, 2008

    Report

    Report Number
    9681834-2008-00030
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K955801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE USER FACILITY INFO, NON-RESORBABLE MATERIAL WAS LEFT UNRETRIEVED IN THE PT'S BODY (ALTHOUGH THE LOCATION IS UNK). INVOLVED DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT NUMBER IS NOT KNOWN. THEREFORE, THE FAILURE INVESTIGATION WAS LIMITED TO ASSESSMENT OF INFO PROVIDED BY THE USER FACILITY. DURING FOLLOW-UP COMMUNICATION, THE REPORTER STATED THAT THE PT IS DOING FINE. AN ADD'L HIGH RESOLUTION CT SCAN HAS BEEN PERFORMED, BUT THE PLASTIC INSERTER COULD NOT BE LOCATED. FURTHER EFFORTS TO LOOK FOR THE INSERTER WERE NOT PLANNED BECAUSE "RISK OF HARM WAS GREATER THAN THE BENEFIT OF REMOVING IT." THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INSERTER IS A FUNNEL-SHAPED PLASTIC ACCESSORY THAT IS ASSEMBLED BY SLIP-FIT TO THE END OF THE COILED HOLDER FOR PACKAGING AND SHIPPING. THE INSERTER IS INTENDED TO BE DETACHED FROM THE HOLDER SO THAT IT CAN BE USED TO ASSIST WITH FEEDING THE DISTAL TIP OF THE GUIDEWIRE INTO THE BACK OF AN INTRODUCER NEEDLE OR SHEATH. NEITHER THE HOLDER NOR THE INSERTER IS INTENDED TO HAVE DIRECT CONTACT WITH THE PT'S BODY. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS FOR THIS PRODUCT REGARDING THIS TYPE OF ISSUE. THE POTENTIAL FOR THIS TYPE OF USER ERROR IS NOT ADDRESSED IN THE DEVICE LABELING. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A FEM-FEM BYPASS PROCEDURE, A PLASTIC ACCESSORY COMPONENT WAS INADVERTENTLY LOST INTO THE SURGICAL INCISION. THE FOLLOWING DETAILS WERE PROVIDED: THE PHYSICIAN WAS FEEDING THE GUIDEWIRE DIRECTLY FROM THE COILED HOLDER INTO THE FEMORAL VEIN; THE ENTIRE END OF THE COILED HOLDER INCLUDING A PLASTIC INSERTER WERE ADVANCED COMPLETELY INTO OPENING OF FEMORAL VEIN; UPON PULLING THE COILED HOLDER BACK, THE PHYSICIAN NOTED THAT THE INTRODUCER WAS NO LONGER "ATTACHED TO THE LOOP"; ATTEMPTS TO LOCATE THE INSERTER BY FLUOROSCOPY, IVUS AND CAT SCAN WERE UNSUCCESSFUL; THE INITIAL PROCEDURE WAS COMPLETED; A VENA CAVA FILTER WAS PLACED IN A SUBSEQUENT PROCEDURE. THE PT'S CONDITION IS LISTED AS FAIR, BUT IS REPORTEDLY UNRELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIFOCUS GLIDEWIRE DQX TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other