BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 6301213 · Received February 3, 2017

    Report

    Report Number
    1820334-2017-00110
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    January 5, 2017
    Report Date
    June 5, 2017
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    10827002523514
    PMA / PMN Number
    K091527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, TRENDS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE WORK ORDER WAS REVIEWED AND ONE NON-CONFORMANCE WAS NOTED FOR DAMAGE. THE DAMAGED DEVICE WAS SCRAPPED; THE WORK ORDER WAS MARKED DOWN AND THEN PROCESSED AS NORMAL. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THERE IS NO EVIDENCE TO SUGGEST THIS PRODUCT WAS NOT MANUFACTURED TO SPECIFICATION. THE INSTRUCTIONS FOR USE (IFU) ADVISE NOT TO EXCEED RATED BURST PRESSURE. OVER-INFLATION MAY CAUSE RUPTURE OF THE BALLOON WITH RESULTANT DAMAGE TO THE VESSEL WALL. THE IFU FURTHER ADVISE TO INSPECT THE CATHETER UPON REMOVAL FROM THE PACKAGE TO ENSURE NO DAMAGE HAS OCCURRED DURING SHIPPING. PHOTOGRAPHIC INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON BURST LONGITUDINALLY. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HAS BEEN ARCHIVED AT THE MANUFACTURING FACILITY. MONITORING WILL BE CONDUCTED FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # : K131204. THE REPORTED EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A TREATMENT OF EIA LESION WAS CONDUCTED BY THE IPSILATERAL GROIN APPROACH. AFTER THE TARGET LESION WAS PRE-DILATED WITH A 35LP(6X20), ANOTHER MANUFACTURER'S STENT WAS PLACED. AFTER THE FIRST INFLATION, THE BALLOON WAS DEFLATED AND MOVED TO ANOTHER POSITION IN THE STENT. UPON THE SECOND BALLOONING ATTEMPT, A BALLOON RUPTURE WAS REVEALED. THE PROCEDURE WAS COMPLETED USING ANOTHER 35LP BALLOON(8X20). THE ALLEGED DEVICE WAS USED FOR POST DILATION OF THIS STENT. THE PATIENT REMAINED UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82654 ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC N/A 10827002523514

    Patients

    Seq Age Sex Outcome Treatment
    1