BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SHEATH INTRODUCER SHEATH

    MDR report key: 1941492 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05773
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DRE
    PMA / PMN Number
    K052557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED IN A STERILE BAG. VISUAL AND MICROSCOPIC ANALYSIS REVEALED THE TOP AND THE SIDE SEAL PARTS OF STERILE BAG HAD BEEN PEELED OFF ABOUT 7CM. THE ADHESIVE MARK WAS OBSERVED AT THE PEELED OFF PART OF THE STERILE BAG. THE SEAL STRENGTH OF THE UNPEELED OFF PART OF THE STERILE BAG WAS MEASURED AND NO ABNORMALITY WAS OBSERVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. IT WOULD BE ASSUMED THAT THE PRODUCT MIGHT HAVE DROPPED OUT FROM THE STERILE BAG IF THE TOP AND THE SIDE SEALING WERE PEELED OFF LIKE THE COMPLAINT STERILE BAG. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED TREATMENT PROCEDURE, A COMPROMISED STERILE PACKAGE BARRIER WAS NOTED. A 6F X 11CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE WHEN IT WAS NOTICED THAT THE DEVICE STERILE PACKAGING WAS OPEN. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED TREATMENT PROCEDURE, A COMPROMISED STERILE PACKAGE BARRIER WAS NOTED. A 6F X 11CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE WHEN IT WAS NOTICED THAT THE DEVICE STERILE PACKAGING WAS OPEN. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    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 H7491603506B0

    Patients

    Seq Age Sex Outcome Treatment
    1