BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER BALLOON CATHETER

    MDR report key: 1503698 · Received September 29, 2009

    Report

    Report Number
    2134265-2009-05325
    Event Type
    Malfunction
    Date Received
    September 29, 2009
    Date of Event
    June 3, 2009
    Report Date
    September 17, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K021721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION REVEALED THAT THE PACKAGE WAS DAMAGED IN 2 AREAS ON ONE SIDE OF THE OUTER POUCH. THE SIDE IS PART OF THE VENDOR POUCH SEAL. THE SEAL TRANSFER IN THE OPENED AREAS WAS LIGHT, INDICATING THAT THE SEAL PRESENT WAS INSUFFICIENT. A HEAVIER SEAL TRANSFER CAN BE SEEN WHEN UNCOMPROMISED AREAS OF THE PACKAGING ARE OPENED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE CLASSIFICATION IS CONSIDERED SUPPLIER MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOT REPORTABLE BASED ON ANALYSIS COMPLETED ON 09/17/2009. IT WAS REPORTED THAT DURING RECEIPT OF THE PRODUCT, PACKAGING DAMAGE WAS NOTED. THE EQL/33/7/2/100 BALLOON ARRIVED WITH THE OUTER PACKAGE DAMAGED. THE PROBLEM WAS NOTICED DURING THE INSPECTION OF THE RECEIVED PRODUCT. THERE WAS NO PT INVOLVEMENT. DEVICE ANALYSIS REVEALED A COMPROMISED OUTER SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC 17-110 12299197

    Patients

    Seq Age Sex Outcome Treatment
    1