BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-G 16 INTODUCER KIT

    MDR report key: 1891393 · Received November 4, 2010

    Report

    Report Number
    9611594-2010-00070
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 1, 2010
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THE PRODUCT MET ALL MANUFACTURING SPECIFICATIONS. SAMPLE EVALUATION SHOWED THE PEEL-AWAY SHEATH WAS NOT PEELED DOWN, IT WAS DAMAGED AT A FEW LOCATIONS ALONG THE TEAR SEAM WHERE IT SPLIT OPEN, AND THERE WERE WITNESS MARKS IN THE SAME AREA INDICATING THAT THE SHEATH WAS BENT OR BUCKLED. THE DILATORS WERE NOT BENT OR BUCKLED, WHICH SUGGESTS THAT THE DILATORS WERE ALREADY ADVANCED THROUGH THE PEEL-AWAY SHEATH AND THAT THE SHEATH DID NOT HAVE ANY INTERNAL SUPPORT/STIFFNESS WHEN IT INCURRED DAMAGE DUE TO BENDING OR BUCKLING. THE DISTAL TIP OF THE CANNULA WAS SLIGHTLY DEFORMED BY THE GUIDEWIRE - THIS EVIDENCE SUGGESTS THAT THE CANNULA WAS ATTEMPTED TO BE ADVANCED OVER A SIGNIFICANT BEND IN THE WIRE. THE DISTAL TIP OF THE SMALLEST DILATOR WAS DEFORMED/PROLAPSED IN A MANNER THAT SUGGESTS THE CANNULA WAS PULLED THROUGH THIS DILATOR, OR THAT THE DILATOR OVER-RODE THE CANNULA. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, " INITIAL REPORTS INDICATE THE SERIAL DILATOR FELL APART PER CUSTOMER PHYSICIAN REPORT:"THIS HAPPENED ON FRIDAY, OCTOBER 1ST. THE PHYSICIAN USING IT SAID SOMETHING ABOUT ONE PART WAS SUPPOSED TO PULL OUT OF THE PATIENT WHILE THE OTHER PART STAYED IN, AND THE OPPOSITE HAPPENED (THE PART THAT WAS SUPPOSE TO STAY IN PULLED OUT AND THE PART THAT WAS SUPPOSE TO PULL OUT STAYED IN)." DILATORS CAME OFF. THEY WERE REMOVED BY THE PHYSICIAN DURING THE PROCEDURE. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED, BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC-G 16 INTODUCER KIT PPK INTRODUCER KIT KNT AA0123R05

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention