BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK

    MDR report key: 19686845 · Received July 7, 2024

    Report

    Report Number
    9616099-2024-00229
    Event Type
    Malfunction
    Date Received
    July 7, 2024
    Date of Event
    April 19, 2024
    Report Date
    August 27, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    PDU
    UDI-DI
    20705032067574
    PMA / PMN Number
    K150836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, SECTION D.4 PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER HAS BEEN CORRECTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    AS REPORTED, THERE WAS HEAVILY A CALCIFIED CTO IN THE LEFT SFA. THE TEAM WAS ABLE TO INITIALLY RETRACT AND DEPLOY THE OUTBACK ELITE NEEDLE, BUT IT FELT STIFFER THAN NORMAL. AFTER FLUSHING IT ANOTHER TIME, WHEN THE PHYSICIAN WENT TO RETRACT THE NEEDLE, HE/SHE NOTICED THAT IT WAS KINKED AND WOULD NO LONGER RETRACT BACK INTO THE HOUSING OF THE OUTBACK. IT NEVER ENTERED THE PATIENT BODY, SO NO HARM WAS DONE TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED PROPERLY. THE TEAM FLUSHED AND REMOVED THE PROTECTIVE CAP OFF THE NEEDLE. ALL SPECIFIED PORTS WERE FLUSHED WITH HEPARINIZED SALINE. THE DEVICE WILL BE RETURNED FOR EVALUATION. A NON-STERILE UNIT OF ¿OUTBACK ELITE 120CM RE-ENTRY¿ WAS RECEIVED FOR ANALYSIS. THE UNIT WAS INSPECTED OBSERVING THAT THE CANULA NEEDLE WAS PARTIALLY RETRACTED. THE HANDLE IS SET IN THE RETRACTED POSITION. THE NEEDLE WAS CLOSELY INSPECTED OBSERVING A KINK WITH A FRACTURED CONDITION LOCATED APPROXIMATELY 4 MM FROM THE DISTAL TIP. FUNCTIONAL ANALYSIS WAS PERFORMED BY ACTUATING THE HANDLE SLIDER TO RETRACT THE NEEDLE CANNULA BACK. THE NEEDLE WAS NOT RETRACTED AS EXPECTED DUE TO THE OBSERVED KINK. THE SLIDER FUNCTIONALLY WAS TESTED ACTUATING IT BACK AND FORWARD AND THE CANNULA WAS RETRACTED AND DEPLOYED. NO ANOMALIES WERE OBSERVED ON THE MECHANISM, EXCEPT FOR THE PARTIAL CANNULA NEEDLE RETRACTION DUE TO THE KINK. SEM ANALYSIS WAS NOT PERFORMED BECAUSE THE DAMAGES ASSOCIATED WITH THE FRACTURE AND THE KINK ARE VISIBLE WITH THE MAGNIFICATION OBTAINED WITH A VISION SYSTEM. THE FRACTURED AND KINKED AREA WAS EVALUATED WITH A VISION SYSTEM, WHICH PRESENTED EVIDENCE OF ELONGATIONS, DIMPLES, AND PLASTIC DEFORMATION. THE REPORTED ¿CANNULA/NEEDLE (OUTBACK ONLY) ~KINKED/BENT¿, ¿CTO CATHETER SYSTEM~PREPPING DIFFICULTY-UNABLE TO RETRACT NEEDLE¿, AND ¿CANNULA/NEEDLE (OUTBACK ONLY) ~ FRACTURED¿ WERE CONFIRMED. THE EXACT CAUSE OF THESE EVENTS CANNOT BE DETERMINED HOWEVER, THE ELONGATIONS, DIMPLES AND PLASTIC DEFORMATION FOUND ON THE MATERIAL OF THE FRACTURE ARE COMMONLY ASSOCIATED WITH DAMAGES CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE DEVICE WAS INDUCED TO A TENSILE/COMPRESSION FORCE THAT EXCEEDED THE MATERIAL YIELD STRENGTH PRIOR TO FRACTURING. PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. USE STERILE TECHNIQUE TO CAREFULLY REMOVE THE OUTBACK® ELITE RE-ENTRY CATHETER FROM THE PACKAGING. INSPECT THE CATHETER FOR DAMAGE.¿ BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE D.

    Description of Event or Problem · 0

    AS REPORTED, THERE WAS HEAVILY CALCIFIED CTO IN THE LEFT SFA. THE TEAM WAS ABLE TO INITIALLY RETRACT AND DEPLOY THE OUTBACK ELITE NEEDLE, BUT IT FELT STIFFER THAN NORMAL. AFTER FLUSHING IT ANOTHER TIME, WHEN THE PHYSICIAN WENT TO RETRACT THE NEEDLE, HE/SHE NOTICED THAT IT WAS KINKED AND WOULD NO LONGER RETRACT BACK INTO THE HOUSING OF THE OUTBACK. IT NEVER ENTERED THE PATIENT BODY, SO NO HARM WAS DONE TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED PROPERLY. THE TEAM FLUSHED AND REMOVED THE PROTECTIVE CAP OFF THE NEEDLE. ALL SPECIFIED PORTS WERE FLUSHED WITH HEPARINIZED SALINE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152420 OUTBACK CATHETER FOR CROSSING TOTAL OCCLUSIONS PDU CORDIS US. CORP 18185053 20705032067574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male