BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASCIAL DILATOR

    MDR report key: 1633305 · Received March 11, 2010

    Report

    Report Number
    1825146-2010-00005
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    February 8, 2010
    Report Date
    February 9, 2010
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    KOE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED PACKAGE CONTAINING A 5FR FACIAL DILATOR WAS RECEIVED. THE DILATOR WAS SEPARATED INTO TWO PIECES, ONE SEGMENT MEASURING 4.3CM WAS RETURNED INSIDE A SPECIMEN CUP NOTING SCRAPE MARKS PRESENT ON THE END OF SEPARATION. THE SECOND SEGMENT WAS BENT 4.5CM FROM THE END OF SEPARATION AND WAS NOTED TO HAVE A STRETCHED APPEARANCE ON THIS PORTION WITH THE REMAINDER OF THE DILATOR INTACT. IN VIEWING THE POINTS OF SEPARATION THE ENDS APPEAR TO HAVE MATING FRACTURES, INDICATING ALL PIECES WERE RECEIVED. OVERALL LENGTH OF BOTH SEGMENTS MEASURE 24.1CM NOTING SPECIFICATION STATES 20CM +2CM/-1CM INDICATING THE DILATOR HAS BEEN STRETCHED 2 TO 5CM, THUS RESULTING IN LONGER OVERALL LENGTH. MOST LIKELY THE DILATOR HAD MET RESISTANCE BELOW THE SKIN, UPON REMOVING THE DILATOR STRETCHING OCCURRED BETWEEN THE LOCATION BEING PULLED AND UP TO THE POINT OF SEPARATION OF THE SEGMENT INSIDE THE PATIENT. THE MARKETED USE OF THIS DILATOR IS FOR UROLOGICAL USE AND WOULD HAVE BEEN USED OFF LABEL.

    Description of Event or Problem · 1

    PATIENT TO THE CATH LAB FOR ANGIOPLASTY. PHYSICIAN PREFERS TO USE THIS DEVICE FOR THIS PROCEDURE. DURING THE PROCEDURE, ADVANCED DILATOR THROUGH SKIN INTO VESSEL. DIFFICULTY ADVANCING THROUGH SCAR TISSUE AT SITE, DIFFICULTY REMOVING DILATORS. THE DISTAL PORTION BROKE OFF INSIDE THE VESSEL. PATIENT WENT TO OPERATING ROOM TO HAVE PORTION REMOVED. CUT DOWN ON THE VESSEL IN THE GROIN AREA PROCEDURE USED TO REMOVE PORTION. NOT SURE WHAT INSTRUMENTS WERE USED TO REMOVE PORTION. ADDITIONAL INFORMATION RECEIVED 2/25/2010: ARTERIAL ACCESS WAS ACHIEVED WITH 18 GA NEEDLE IN THE LEFT GROIN. SURGEON ATTEMPTED TO INSERT A 5FR SHEATH OVER THE GUIDEWIRE AND DUE TO SEVERE SCAR TISSUE WAS UNABLE TO ACHIEVE ACCESS. THE 5FR COOK FASCIAL DILATOR WAS SELECTED TO ACHIEVE ACCESS. AS THE DILATOR WAS ADVANCED RESISTANCE WAS NOTED. DILATOR WAS WITHDRAWN AND IT WAS NOTED BY THE RN THAT THE DILATOR WAS "CRIMPED" AND THAT A "1 1/2" INCH TIP OF THE DILATOR WAS MISSING. SURGEON PALPATED THE AREA AND ATTEMPTED TO MANUALLY RETRIEVE THE TIP. DECISION WAS MADE TO TAKE THE PATIENT TO THE OPERATING ROOM FOR OPEN EXPLORATION AND REMOVAL OF THE FOREIGN BODY. FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASCIAL DILATOR KOE DILATOR, URETHRAL KOE COOK UROLOGICAL INC NA U1882499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention