BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER 14S (OTW)

    MDR report key: 4810745 · Received May 22, 2015

    Report

    Report Number
    2020394-2015-00688
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    August 2, 2013
    Report Date
    August 2, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K091119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICAL REVIEW OF THIS EVENT WAS PERFORMED AND IDENTIFIED THE EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. A MFG REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR CORPORATE LOT NUMBER # FCXF10004. THE DEVICE WAS RETURNED. THE COMPLAINT INVESTIGATION IS CONFIRMED FOR CATHETER FAILING TO ADVANCE AND RETRACT THROUGH THE MICRO SHEATH. DURING EVAL OF THE RETURNED DEVICE, IT WAS NOTED THAT THE CATHETER HAD BEEN ADVANCED APPROXIMATELY 20.5CM OUT THE MICRO SHEATH. THE MICRO SHEATH AND CROSSER IFUS BOTH NOTE THAT THE CROSSER CAN ONLY BE ADVANCED APPROXIMATELY 15CM FROM THE TIP OF THE TAPERED MICRO SHEATH. AS THE CATHETER HAD BEEN ADVANCED PAST THE ALLOWABLE DISTANCE STATED IN THE IFU, IT IS LIKELY THAT THE TAPERS OF BOTH THE CROSSER AND MICRO SHEATH HAD ALIGNED AND LOCKED UP AT THE TIME OF THE EVENT. BASED ON THE RESULTS OF THE INVESTIGATION, THE TWO DEVICES LIKELY LOCKED UP DUE TO THE USER ADVANCING THE CROSSER TOO FAR PAST THE END OF THE SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECANALIZATION CATHETER GOT STUCK WITHIN THE SUPPORT CATHETER DURING USE. REPORTEDLY, THE RECANALIZATION CATHETER WAS INSERTED UP AND OVER THE HORN AND USED FOR LESS THAN 5 MINUTES WHEN IT BECAME STUCK IN THE MICRO SHEATH AND WOULD NOT ADVANCE ANY FURTHER. IT WAS ALSO REPORTED THAT FORCE WAS APPLIED TO THE RECANALIZATION CATHETER, ENABLING IT TO EXIT THE SUPPORT CATHETER; HOWEVER, THE RECANALIZATION CATHETER BECAME DAMAGED. ANOTHER RECANALIZATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335420 CROSSER 14S (OTW) DQY BARD PERIPHERAL VASCULAR, INC. FCXF10004

    Patients

    Seq Age Sex Outcome Treatment
    1