BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 3970098 · Received April 29, 2014

    Report

    Report Number
    1820334-2014-00189
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K091527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER INFORMATION SUPPLIED BY THE CUSTOMER, NO PRODUCT WILL BE RETURNED. QUALITY CONTROL CHECKS INSIDE DIAMETER OF BALLOON FOR EXCESSIVE FOREIGN MATTER, AND CHECK FOR SURFACE DEFECTS. THIS PRODUCT IS SHIPPED WITH INSTRUCTIONS FOR USE WHICH STATES UNDER DEVICE DESCRIPTION: "PARTICULAR CARE SHOULD BE TAKEN IN HANDLING THE BALLOON TO PREVENT DAMAGE. IT WILL INFLATE TO THE INDICATED SIZE PARAMETERS WHEN UTILIZING PROPER PRESSURE RECOMMENDATIONS. ADHERE TO BALLOON INFLATION PRESSURE PARAMETERS INDICATED IN THE COMPLIANCE CARD INSERT." WARNINGS: "DO NOT EXCEED RATED BURST PRESSURE. RUPTURE OF BALLOON MAY OCCUR. 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." INSTRUCTIONS FOR USE - BALLOON INTRODUCTION AND INFLATION STEP 4: "INFLATE BALLOON TO DESIRED PRESSURE. ADHERE TO RECOMMENDED BALLOON INFLATION PRESSURES. (SEE COMPLIANCE CARD INSERT.) STEP 5: "IF BALLOON PRESSURE IS LOST AND/OR BALLOON RUPTURE OCCURS, DEFLATE BALLOON AND REMOVE BALLOON AND SHEATH AS A UNIT." THE CUSTOMER STATED THEY INFLATED THE BALLOONS TO 23 ATM AND THAT THEY BURST HORIZONTALLY INSTEAD OF LONGITUDINALLY. THE RECOMMENDED NOMINAL INFLATION PRESSURE IS 10 ATM AND RATED BURST PRESSURE IS 15 ATM. THE CUSTOMER INFLATING THE BALLOON ABOVE THE RECOMMENDED INFLATION PRESSURE IS WHAT CAUSED THIS FAILURE MODE TO OCCUR. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. QUALITY ENGINEERING RISK ASSESSMENT WAS USED TO ASSESS THE RISK OF THIS COMPLAINT. THE ADDITION OF THIS COMPLAINT DOES NOT CHANGE THE CONCLUSION THAT NO FURTHER RISK REDUCTION IS REQUIRED.

    Description of Event or Problem · 1

    A PATIENT WITH IN STENT RE-STENOSIS EXTERNAL ILIAC ARTERY UNDERWENT A PTA EXTERNAL ILIAC ARTERY ON (B)(6) 2014. CUSTOMER TREATED AN EXTERNAL ILIAC LESION WITH IN ISR WITH A 7-2 (1820334-2014-00188) AND 6-2 (1820334-2014-00189) 35LP BALLOON. CUSTOMER INFLATED UP TO 23 ATM AND AFTER THAT BOTH BALLOONS RUPTURED. BOTH BALLOONS DID NOT RUPTURE IN THE LONGITUDINAL WAY, BUT HORIZONTALLY IN THE MIDDLE. ONE OF THE BALLOONS GOT PICKED BY THE SHEATH AND IT CAUSED THEM A LOT OF WORK TO GET EVERYTHING OUT THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255503 ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DQY: CATHETER, PERCUTANEOUS DQY COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP