BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 2020713 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00917
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED IN A SEALED INNER PACKAGING POUCH. THE FRONT OF THE POUCH EXHIBITED CREASES CORRESPONDING WITH THE EDGE OF THE PACKAGING CARD THAT HOLDS THE CATHETER. THERE WERE SHORT TEARS WITHIN THE CREASES. IN SOME LOCATIONS, THE TEARS APPEARED AS A PATTERN OF CONSECUTIVE TEARS WITH SIMILAR LENGTH AND ORIENTATION. AT THE RIGHT SIDE OF THE PACKAGING CARD, THE POUCH WAS DAMAGED 12.1-32, 41.8-60.1 AND 63.5-83.0 CM FROM THE TOP OF THE PACKAGING CARD. AT THE LEFT EDGE OF THE PACKAGING CARD, THE POUCH WAS DAMAGED FROM 14.5-24.6 CM FROM THE TOP OF THE PACKAGING CARD. 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 A MACH 1 GUIDE CATHETER WAS RECEIVED AT THE HOSPITAL WITH "RATHER DAMAGED PACKAGING". DUE TO THE DAMAGE IT WAS THOUGHT THAT THE STERILITY HAD BEEN COMPROMISED. THE DEVICE WAS NOT USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MACH 1 GUIDE CATHETER WAS RECEIVED AT THE HOSPITAL WITH "RATHER DAMAGED PACKAGING". DUE TO THE DAMAGE IT WAS THOUGHT THAT THE STERILITY HAD BEEN COMPROMISED. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74934356220 0050560531

    Patients

    Seq Age Sex Outcome Treatment
    1