BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER BALLOON CATHETER

    MDR report key: 1771574 · Received July 27, 2010

    Report

    Report Number
    2134265-2010-03228
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQY
    PMA / PMN Number
    K021721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: VISUAL AND MICROSCOPIC ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT A SHAFT KINK WAS FOUND NEAR THE BIFURCATION AND A BALLOON TEAR WAS FOUND NEAR THE DISTAL BOND. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING, A HOLE IN THE BALLOON WAS NOTED. A (B)(4) EQUALIZER BALLOON CATHETER WAS SELECTED FOR USE AND DURING UNPACKING A HOLE IN THE BALLOON WAS NOTED. THE PROCEDURE OUTCOME IS UNKNOWN AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING, A HOLE IN THE BALLOON WAS NOTED. A 33/7/2/100 EQUALIZER BALLOON CATHETER WAS SELECTED FOR USE AND DURING UNPACKING A HOLE IN THE BALLOON WAS NOTED. THE PROCEDURE OUTCOME IS UNKNOWN AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER BALLOON CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK M001171100

    Patients

    Seq Age Sex Outcome Treatment
    1