BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITRACK 250A

    MDR report key: 8597977 · Received May 9, 2019

    Report

    Report Number
    3005641545-2019-00001
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 28, 2019
    Manufacturer
    ELLEX ISCIENCE INC.
    Product Code
    HMX
    UDI-DI
    00893872001059
    PMA / PMN Number
    K080067
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED CATHETER FROM ITRACK LOT# 1810-05 WAS RECEIVED, DECONTAMINATED AND EVALUATED. THE VISUAL INSPECTION OF THE RETURNED CATHETER FINDS A SEVERELY KINKED AND TORN AREA ON THE DISTAL SHAFT TUBING AROUND 3MM FROM THE TIP. THEREFORE OPTIC FIBER AND SUPPORTING WIRE WERE KINKED AND EXPOSED OUT OF THE CATHETER. THIS INDICATES THAT THERE WAS AN EXCESSIVE FORCE APPLIED BY FORCEPS WHILE PERFORMING THE PROCEDURE AND PROBABLY A LOT OF MANIPULATION WHEN TRYING TO INTUBATE THE SCHLEMMS CANAL . THE DEGREE OF DAMAGE TO THE CATHETER SUGGESTS INAPPROPRIATE HANDLING/USER ERROR. THE PATIENT HAS HAD PERSISTENT INFLAMMATORY DEBRIS AND WILL LIKELY UNDERGO A VITRECTOMY TO REMOVE THE MATERIAL. ELLEX CLINICAL SPECIALIST HAS CONTACTED THE USER TO INITIATE A VISIT FOR ADDITIONAL CLINICAL SUPPORT TO ENSURE THAT THE USER IS PROPERLY HANDLING THE CATHETER. (B)(4).

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP REPORT . THE PATIENT HAS HAD PERSISTENT INFLAMMATORY DEBRIS AND WILL LIKELY UNDERGO A VITRECTOMY TO REMOVE THE MATERIAL. THIS REPORT IS MADE BY ELLEX ISCIENCE WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    AS SOON AS ELLEX I.SCIENCE BECAME AWARE OF THE EVENT, THE PHYSICIAN WAS CONTACTED BY ELLEX CHIEF MEDICAL OFFICER FOR FURTHER DETAILS. THE PATIENT HAD DEVELOPED A SEVERE INFLAMMATORY REACTION IMMEDIATELY FOLLOWING CANALOPLASTY BUT HAS BEEN IMPROVING. THE DEVICE LOT HAD PASSED ALL DEVICE PERFORMANCE AND STERILITY TESTS PRIOR TO RELEASE. THE CONCERNED DEVICE WAS REQUESTED BACK FROM THE USER AND IS UNDER FURTHER EVALUATION. A FOLLOW UP REPORT SHALL BE PROVIDED WITH UPDATES ON THE PATIENT STATUS AND DEVICE INVESTIGATION. REVIEW OF THE LOT HISTORY RECORD FOR ITRACK LOT# 1810-05 FINDS THAT THESE WERE BUILT USING APPROVED MATERIAL AND RELEASED PROCEDURES BY TRAINED OPERATORS. NO ANOMALIES WERE REPORTED.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT THE PATIENT ON WHOM HE PERFORMED THE CANALOPLASTY, DEVELOPED SEVERE INFLAMMATORY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387332 ITRACK 250A CANNULA, OPHTHALMIC HMX ELLEX ISCIENCE INC. IT-250A 1810-05 00893872001059

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R