BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 2032591 · Received March 22, 2011

    Report

    Report Number
    1820334-2011-00152
    Event Type
    Injury
    Date Received
    March 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K091527
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT) UNK AS NOT PROVIDED BY REPORTER. (B)(4). NOT PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. QC VERIFIES PROFILE OF FOLDED BALLOON AND BOND AREA. BALLOONS ARE INSPECTED FOR THE CORRECT NUMBER OF FOLDS. THE INSTRUCTIONS FOR USE (IFU) STATES "MAINTAIN A VACUUM ON THE BALLOON DURING THE WITHDRAWAL OF THE DEVICE." WITHOUT THE COMPLAINT DEVICE WE CANNOT MAKE A DEFINITE ROOT CAUSE ANALYSIS. THE IFU CAUTIONS TO ENSURE BALLOON IS COMPLETELY DEFLATED AND IF RESISTANCE IS MET TO "APPLY NEGATIVE PRESSURE WITH A LARGER SYRINGE." LESION MORPHOLOGY MAY HAVE CONTRIBUTED TO SEPARATION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO MITIGATING ACTIONS ARE REQUIRED AT THIS TIME DUE TO INSUFFICIENT RISK.

    Description of Event or Problem · 1

    UPON WITHDRAWING THE BALLOON DURING AN ILIAC ANGIOPLASTY, THE TIP OF THE CATHETER SHEARED OFF INTO THE PT. THEY WERE ABLE TO RETRIEVE THE SEGMENT WITH NO HARM TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention