BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    MDR report key: 20748346 · Received November 21, 2024

    Report

    Report Number
    3015551113-2024-00004
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    November 1, 2024
    Report Date
    February 28, 2025
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595006197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE LOT NUMBER PROVIDED IN THE INITIAL REPORT WAS INCORRECT. THE CORRECT LOT NUMBER, AS STATED IN THE FOLLOW-UP REPORT, IS 408294197.

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RECEIVED AND THE USER REPORTED ISSUE WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED NO EVIDENCE THAT A SEAL HAD BEEN ATTEMPTED OR MADE. POUCH SEALING WAS COMPLETED BY A TRAINED OPERATOR 13SEP2024 USING MP0390RL. ALL RELEVANT TOOLING AND EQUIPMENT WERE FOUND TO HAVE BEEN APPROPRIATELY MAINTAINED AND WITHIN CALIBRATION INTERVALS AS APPLICABLE. ALL IN-PROCESS POUCH SEAL PEEL VALUES RECORDED DURING PRE-SEAL TESTING AND POST-SEAL TESTING OF LOT: 408294197 WAS WITHIN SPECIFICATION WITH NO APPRECIABLE SHIFT VERSUS LOTS PROCESSED BEFORE AND AFTER LOT: 408294197 UPON REVIEW. SEALER PARAMETER SET POINTS WERE SET ACCORDING TO MP0390RL. AN AWARENESS NOTIFICATION WAS SENT TO SHIFT GROUP LEADS AND THE PRODUCTION SUPERVISOR, MAKING THEM AWARE OF THE ISSUE AS WELL AS THE POTENTIAL EFFECTS OF FAILURE TO FOLLOW PACKAGING REQUIREMENTS. FORMAL RETRAINING WILL BE PROVIDED UPON RELEASE OF REVISED PACKAGING PROCEDURES. THERE WAS NO EVIDENCE THAT THERE WAS ANY FAILURE OF EQUIPMENT OR REPEAT OPERATOR ERROR. THERE WAS NO EVIDENCE THAT ANY OTHER DEVICES IN THE FIELD WOULD BE LIKELY TO HAVE BEEN AFFECTED BY THIS NON-CONFORMANCE, AS SUCH THIS ISSUE APPEARS ISOLATED TO THE RETURNED CATHETER. A 12 MONTH REVIEW OF PRIOR COMPLAINTS REVEALS NO OTHER COMPLAINTS FOR TVC-C195-42 POUCH SEALING FAILURES. ON DECEMBER 1ST, 2024, FOCUS MEDICAL REPLIED THAT NONE OF LOT: 408294197 REMAINED IN THEIR WAREHOUSE INVENTORY. DUE TO CURRENT DISTRIBUTOR INVENTORY SITUATION, IT IS ANTICIPATED THAT ALL CATHETERS FROM LOT: 408294197 HAVE BEEN CONSUMED. THIS ISSUE APPEARS ISOLATED IN NATURE AND DID NOT RESULT IN ADVERSE CLINICAL OUTCOME SINCE THE PHYSICIAN DETECTED THE PACKAGING ERROR PRIOR TO USE. IFU0958RA INDICATES "PRIOR TO USE, ENSURE THAT THE CATHETER AND STERILE PACKAGING HAVE NOT BEEN DAMAGED OR BREACHED AND THAT NO PARTICULATE IS PRESENT INSIDE THE CATHETER." THIS INSTRUCTION WAS FOLLOWED. IN AN EFFORT TO PREVENT RECURRENCE, ECO-001858 HAS BEEN ROUTED FOR APPROVAL TO ADD AN ADDITIONAL CONTROL TO REDUCE THE RISK OF UNSEALED POUCH ESCAPE. A LOT TREND ANALYSIS OF THE ASSOCIATED PRODUCT LOT: (408294197, FINISHED QTY 200) REVEALED NO OTHER COMPLAINTS FOR "STERILE BARRIER ISSUE" OR KEY WORDS "POUCH" OR "SEAL". THEREFORE, THERE IS NO EVIDENCE TO SUGGEST THAT THIS LOT WAS PREDISPOSED TO POUCH SEALING ISSUES. AS PREVIOUSLY DOCUMENTED, THERE WAS NO PATIENT INJURY REPORTED AND NO PATIENT TREATMENT REQUIRED AS A RESULT OF THE DEVICE MALFUNCTION. THE INVESTIGATION OF THIS COMPLAINT WILL BE CLOSED AFTER THE FILLING OF THIS FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. THE TECHNICIAN OPENED THE NIRS-IVUS CATHETER BOX AND FOUND THAT THE INNER POUCH WAS UNSEALED. THEY IMMEDIATELY REPLACED THE CATHETER. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138938 DUALPRO¿ IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 408291197 00857595006197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown