BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 6394858 · Received March 10, 2017

    Report

    Report Number
    1820334-2017-00365
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 9, 2017
    Report Date
    February 9, 2017
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    10827002523521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # : K131204. INVESTIGATION - THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT VISUAL, DIMENSIONAL, AND/OR FUNCTIONAL TESTING OF THE PRODUCT, WE ARE UNABLE TO DETERMINE IF THIS IS A MANUFACTURING ISSUE. HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THAT PRODUCT WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THERE IS NO EVIDENCE TO SUGGEST ALL ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD ARE NONCONFORMING OR DEFECTIVE. THERE IS NO EVIDENCE THE PRODUCT WAS DAMAGED ON OPENING. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENTS, AND THAT THE DEVICE MEETS THE NEEDS OF THE USER. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE: WARNINGS: "DO NOT EXCEED RATED BURST PRESSURE. RUPTURE OF BALLOON MAY OCCUR. ADHERE TO BALLOON INFLATION PRESSURE PARAMETERS IN THE COMPLIANCE CARD INSERT. OVER-INFLATION MAY CAUSE RUPTURE OF THE BALLOON, WITH RESULTANT DAMAGE TO THE VESSEL WALL. USE OF A PRESSURE GAUGE IS RECOMMENDED TO MONITOR INFLATION PRESSURES. DO NOT USE POWER INJECTOR FOR BALLOON INFLATION OF CONTRAST MEDIUM THROUGH CATHETER LUMEN MARKED "DISTAL." RUPTURE MAY OCCUR." INSTRUCTIONS FOR USE: "UPON REMOVAL FROM PACKAGE, INSPECT THE CATHETER TO ENSURE NO DAMAGE HAS OCCURRED DURING SHIPPING." BALLOON INTRODUCTION AND INFLATION: "INFLATE BALLOON TO DESIRED PRESSURE ADHERE TO RECOMMENDED BALLOON INFLATION PRESSURES. BASED UPON THE INFORMATION PROVIDED A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT IS NOT DETERMINED, HOWEVER IT IS PLAUSIBLE TO SUGGEST THAT THIS INCIDENT WAS HUMAN ANATOMY RELATED. A QUALITY ENGINEER RISK ASSESSMENT WAS CONDUCTED TO ASSESS THE RISK OF THIS FAILURE MODE AND CONCLUDED A CHANGED IS NOT REQUIRED, THUS NO RISK REDUCTION ACTIVITIES ARE REQUIRED AT THIS TIME. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ANOTHER MANUFACTURER'S STENTS WERE PLACED IN THE RIGHT AND LEFT ILIAC ARTERIES BY LEFT COMMON FEMORAL ARTERY APPROACH. AFTER STENT DEPLOYMENT, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED FOR POST-DILATION HOWEVER, THE BALLOON RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE REPORTER STATED THAT THE DEVICE WOULD NOT BE RETURNED DUE TO INFECTIOUS DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178024 ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC N/A 10827002523521

    Patients

    Seq Age Sex Outcome Treatment
    1