BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHE

    MDR report key: 3703804 · Received March 5, 2014

    Report

    Report Number
    3004672932-2014-00001
    Event Type
    Injury
    Date Received
    March 5, 2014
    Date of Event
    October 2, 2013
    Report Date
    March 5, 2014
    Manufacturer
    ONSET MEDICAL CORPORATION
    Product Code
    EZN
    PMA / PMN Number
    K043254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS AND CONCLUSION: THE RETURNED DEVICE ARRIVED AT ONSET MEDICAL (B)(4) 2014. UPON REMOVAL FROM THE PACKAGING, THE PATHWAY BEUS DEVICE APPEARED FULLY EXPANDED AND THE DILATOR AND SHEATH WERE SEPARATED FROM ONE ANOTHER (TWO PIECES). AFTER BEING PROPERLY DECONTAMINATED, THE DEVICE WAS EVALUATED UNDER STANDARD LABORATORY CONDITIONS. THE UNIT APPEARED NORMAL WITH NO OBVIOUS DEFECTS. AN INFLATION SYRINGE WAS ATTACHED TO THE BALLOON DILATOR AND INFLATION WAS ATTEMPTED. FLUID IMMEDIATELY BEGAN TO FLOW FROM THE DISTAL PORTION OF THE BALLOON. UPON INSPECTION, A TEAR OF APPROX 4-5MM WAS IDENTIFIED IN THE MOST DISTAL SECTION OF THE BALLOON UP TO THE BONDED AREA OF THE DISTAL TIP. THE SHEATH APPEARED TO BE FULLY EXPANDED ALONG THE ENTIRE LENGTH; HOWEVER, A SMALL TEAR IN THE DISTAL TIP WAS NOTED. THE DILATOR WAS INSERTED BACK INTO THE SHEATH AND THE TEAR IN THE BALLOON APPEARED TO ALIGN WITH THE SLIGHT TEAR IN THE SHEATH. A SPECIFIC ROOT CAUSE(S) FOR THE DILATOR BURST COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, THE EVAL AND REPORTED EVENTS WOULD SEEM TO INDICATE THAT THE SHEATH AND BALLOON INFLATED AS INTENDED, AS THE SHEATH WAS FULLY EXPANDED, BUT THE DISTAL BALLOON TIP AND SHEATH TIP MAY HAVE BECOME DAMAGED CAUSING THE BALLOON TO RUPTURE DURING INFLATION. A POTENTIAL ROOT CAUSE(S) MAY BE ATTRIBUTED TO THE SHEATH'S DISTAL TIP CONTACTING A STONE OR STONE FRAGMENT DURING EXPANSION THAT MAY HAVE TORN THE BALLOON AND SHEATH RESULTING IN A PREMATURE BALLOON BURST. EXPANSION OF THE SHEATH OVER A STONE OR STONE FRAGMENT MAY HAVE ALSO CONTRIBUTED TO POTENTIALLY PUSHING IT INTO THE URETER RESULTING IN THE REPORTED URETERAL RUPTURE. THESE POTENTIAL ROOT CAUSES ARE CONSISTENT WITH THE POTENTIAL FAILURE MODES OF THIS DEVICE, WHICH HAVE PREVIOUSLY BEEN IDENTIFIED, ADDRESSED, AND MITIGATED BY THOROUGH DEVICE QUALIFICATION TESTING DURING THE DESIGN EVAL. AS PART OF THE INVESTIGATION, THE DEVICE HISTORY RECORD OF THE AFFECTED LOT, W035538, WAS REVIEWED AND THERE WERE NO DISCREPANCIES RECORDED. THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE SPECIFIED REQUIREMENTS. ONSET MEDICAL WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE FOR THIS FAILURE MODE; THEREFORE, NO IMMEDIATE CORRECTIVE ACTION CAN BE DETERMINED AT THIS TIME. HOWEVER, IN ORDER TO ACHIEVE OPTIMUM DEVICE PERFORMANCE IT IS HIGHLY RECOMMENDED FOR THE USER TO REFERENCE THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) PRIOR TO USE FOR OPTIMAL SHEATH POSITIONING AND EXPANSION OF THE DEVICE.

    Description of Event or Problem · 1

    AS REPORTED: ACCESS SHEATH WAS INSERTED INTO THE URETER INTO A PREVIOUSLY STENTED PT. INFLATED TO 25ATM. THE EDGE OF THE BALLOON THAT PROTRUDES THE ACCESS SHEATH BURST ABOUT 45 SECONDS INTO THE HOLD, RUPTURING THE URETER. DOUBLE J STENTED INSERTED AND URETER ALLOWED TO HEAL. SUBSEQUENT 6 WEEK F/U TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133497 PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHE INTRODUCER EZN ONSET MEDICAL CORPORATION 255108 W035538

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention