BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO GLIDESHEATH

    MDR report key: 1791036 · Received July 30, 2010

    Report

    Report Number
    9681834-2010-00019
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    TERUMO CORP., ASHITAKA
    Product Code
    DYB
    PMA / PMN Number
    K033681
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE INVOLVED INTRODUCER SHEATHS NOR OTHER DEVICES USED DURING THE PROCEDURE WERE RETAINED BY THE USER FACILITY AND THE LOT NUMBERS ARE UNK. THEREFORE, THE INVESTIGATION WAS LIMITED TO AN ASSESSMENT OF INFO PROVIDED BY THE USER FACILITY AND NON-SPECIFIC QUALITY RECORDS. THE USER FACILITY IDENTIFIED TWO GLIDESHEATH PRODUCT CODES THAT WERE REPORTEDLY USED DURING THE PROCEDURE. THE OTHER REPORTED PRODUCT CODE WAS RM*BF5F10PA (5-FR. GLIDESHEATH). AS STATED ABOVE, THE INVOLVED DEVICES WERE NOT RETURNED FOR EVALUATION AND THE LOT NUMBERS ARE UNK. THEREFORE, THE FAILURE INVESTIGATION WAS LIMITED TO ASSESSMENT OF INFO PROVIDED BY THE USER FACILITY AND A REVIEW OF GENERAL RECORDS FOR THE REPORTED PRODUCT FAMILY COVERING THE LAST 3-YEARS. THIS REVIEW DID NOT IDENTIFY ANY POTENTIALLY RELATED MFG OR STERILIZATION ISSUES. IN ADDITION, IT WAS CONFIRMED THAT THERE HAVE NOT BEEN ANY SIMILAR COMPLAINTS FOR THIS PRODUCT FAMILY. THERE IS NO INDICATION THAT THERE WAS ANY RELATION TO A PRE-EXISTING DEVICE DEFECT. THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFO. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE AT THE MFG FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PT DEVELOPED A REACTION AT ACCESS SITE ON THE RIGHT WRIST FOLLOWING AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PT'S SKIN NEAR THE ACCESS SITE DEVELOPED WHAT "LOOKED LIKE A RASH" THAT THEN "BECAME OOZING PUS." THE PT WAS GIVEN CEPHALEXIN 500ML AND BACITRACIN TO TREAT THE CONDITION AND IS REPORTED TO BE "GETTING BETTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO GLIDESHEATH DYB TERUMO CORP., ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention JACKY CATHETER TIGER CATHETER| 5-FR. GLIDESHEATH| PROWATER| EBU3.5 LAUNCHER| ANGIOMAX| MAVERICK 308