BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SHEATH INTRODUCER SHEATH

    MDR report key: 1963014 · Received January 18, 2011

    Report

    Report Number
    2134265-2010-05998
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Report Date
    December 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DRE
    PMA / PMN Number
    K052557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED ALONG WITH FOUR OTHER SETS OF SIMILAR DEVICES WITH DIFFERENT BATCH NUMBERS. ONE SET OF DEVICES WAS ALREADY OPENED. THE INVESTIGATION REVEALED THAT A STRANGE OILY LIQUID WAS NOT OBSERVED ON THE RETURNED PRODUCTS OR ON THE STERILE BAGS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNPACKING THE SHEATH, THE INSIDE OF THE STERILE PACKAGING WAS CONTAMINATED. AS THE 5FR X 11 CM SUPER SHEATH WAS UNPACKED AND AN "OILY LIQUID" WAS NOTED INSIDE THE STERILE PACKAGING. THE DEVICE WAS NOT USED DURING THE PROCEDURE AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNPACKING THE SHEATH, THE INSIDE OF THE STERILE PACKAGING WAS CONTAMINATED. AS THE 5FR X 11 CM SUPER SHEATH WAS UNPACKED AND AN "OILY LIQUID" WAS NOTED INSIDE THE STERILE PACKAGING. THE DEVICE WAS NOT USED DURING THE PROCEDURE AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER SHEATH INTRODUCER SHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE BOSTON SCIENTIFIC - MAPLE GROVE M00115961B1 10F02B6

    Patients

    Seq Age Sex Outcome Treatment
    1