BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX (TM)

    MDR report key: 2211469 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03338
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE MIDSHAFT. THE BREAK WAS LOCATED AT 2.5CM DISTAL TO THE PROXIMAL EDGE OF THE MIDSHAFT. AN EXAMINATION OF THE BREAK SITE IDENTIFIED NO ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. NO ISSUES WERE NOTED WITH THE PROFILES OF THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THIS DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 THE PREPARATION FOR A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. WHILE THE SCRUB TECH WAS REMOVING THE 3.0X32MM VERIFLEX STENT DELIVERY SYSTEM FROM THE PACKAGING HOOP, THE DISTAL POLYMER PORTION OF THE SHAFT BROKE WHERE IT MEETS THE HYPOTUBE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION FOR A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. WHILE THE SRCUB TECH WAS REMOVING THE 3.0X32MM VERIFLEX STENT DELIVERY SYSTEM FROM THE PACKAGING HOOP, THE DISTAL POLYMER PORTION OF THE SHAFT BROKE WHERE IT MEETS THE HYPOTUBE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFLEX (TM) STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY H7493893432300 12777014

    Patients

    Seq Age Sex Outcome Treatment
    1