BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT

    MDR report key: 12286478 · Received August 6, 2021

    Report

    Report Number
    9681834-2021-00144
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 29, 2021
    Report Date
    August 6, 2021
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. THE PICTURES PROVIDED BY THE USER SHOWED THAT THE ACTUAL SAMPLE HAD BEEN SEPARATED INTO THREE PORTIONS. VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED THAT IT HAD BEEN CUT AND SEPARATED IN TWO PORTIONS. (NOTE: BASED ON THE DESCRIPTION OF THE COMPLAINT, IT WAS KNOWN THAT THE MID PORTION HAD BEEN DISCARDED BY THE FACILITY.) IN ADDITION, SEVERAL DENTS WITH ALMOST EQUAL INTERVALS (ABOUT 6 MM) WERE OBSERVED NEAR THE CUT ENDS. THE LENGTH OF THE DISTAL PORTION WAS APPROXIMATELY 765 MM AND THE PROXIMAL PORTION WAS APPROXIMATELY 534 MM. (NOTE: BASED ON THE DESCRIPTION OF THE COMPLAINT, IT WAS CONFIRMED BY THE FACILITY AFTER THE CASE THAT NO DAMAGED PORTION REMAINING IN THE PATIENT BODY.) MAGNIFYING INSPECTION OF THE CUT ENDS OF BOTH PORTIONS FOUND THAT THE CUTS ENDS HAD BEEN SQUEEZED AND THE STAINLESS-STEEL REINFORCEMENT WAS EXPOSED. IN ADDITION, THE AXIS AT THE SQUEEZED SECTION HAD BEEN MISALIGNED. THE OUTER AND INNER DIAMETERS OF THE ACTUAL SAMPLE WERE MEASURED AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. SIMULATION TEST: INSERT A FACTORY-RETAINED PROGREAT INTO A FACTORY-RETAINED ANGIOGRAPHIC CATHETER WITH STOPCOCK (GLIDECATH): THE SWITCH COCK WAS TURNED BY 90° AND BY 45° AT POINT A AND POINT B RESPECTIVELY. THE PROGREAT WAS TAKEN OUT FROM THE GLIDECATH AND THE APPEARANCE WAS CHECKED. AS A RESULT, TWO CUTS WITH 6 MM INTERVAL OCCURRED AT POINT A AND TWO DENTS WITH 6 MM INTERVAL OCCURRED AT POINT B. MAGNIFYING INSPECTION OF THE TEST SAMPLE FOUND THAT THE CUT ENDS HAD BEEN SQUEEZED AND THE STAINLESS STEEL REINFORCEMENT WAS EXPOSED. IN ADDITION, THE AXIS AT THE SQUEEZED SECTION HAD BEEN MISALIGNED. THIS STATE WAS FOUND SIMILAR TO THAT OF THE ACTUAL SAMPLE. FROM THIS SIMULATION TEST RESULT, IT WAS LIKELY THAT THE MID PORTION OF THE ACTUAL SAMPLE WAS 6 MM IN LENGTH. IFU SATES: IF THE GUIDING CATHETER IS FITTED WITH A STOPCOCK, DO NOT CLOSE THE STOPCOCK WITH THE CATHETER INSIDE THE GUIDING CATHETER. THE CATHETER MAY BE BROKEN. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT WHILE THE ACTUAL SAMPLE WAS LOCATED INSIDE THE CONCURRENTLY USED DEVICE, THE STOPCOCK OF THE CATHETER WAS MANIPULATED. DUE TO THIS, THE ACTUAL SAMPLE WAS TRAPPED AND SQUEEZED BY THE STOPCOCK, LEADING TO THE CUTS AND DENTS OF THE SHAFT. IN ADDITION, THE FOLLOWING WERE THOUGHT TO BE THE CAUSES OF THE RESISTANCE WHEN MOVING THE ACTUAL SAMPLE FORWARD: THE ACTUAL SAMPLE WAS IN THE STATE OF HAVING BEEN TRAPPED IN THE STOPCOCK; DUE TO THE CUTS AND DENTS ON THE ACTUAL SAMPLE, THE PUSHING FORCE WAS NOT TRANSMITTED TO THE DISTAL SECTION WHEN THE ACTUAL SAMPLE WAS PUSHED FORWARD. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    UDI: NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K033913. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE USER FACILITY PROVIDED PICTURES OF THE ACTUAL SAMPLE WHICH REVEALED THAT IT HAD BEEN BROKEN IN THREE PIECES. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE PROGREAT WAS USED DURING THE TACE CASE. DURING THE PROCEDURE, THE USER COMPLAINED THERE WAS SOME RESISTANCE DURING ADVANCING THE MICROCATHETER. THEY DECIDED TO CHECK THE PROGREAT AND THEY FOUND THAT THE MC WAS BROKEN INTO THREE PIECES THERE WAS NO REMAINING DAMAGED PART LEFT INSIDE THE HUMAN BODY. THE USER OPENED ANOTHER PROGREAT TO FINISH THE CASE. AFTER THE CASE, THE SISTER HAD USED A RULER TO CHECK THE THREE BROKEN PART, AND ALL DAMAGED THE PART TOTAL LENGTH IS AROUND 130CM; NO DAMAGED COMPONENT LEFT INSIDE THE PATIENT'S BODY. THE PATIENT WAS NOT HARMED. THE PROCEDURE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187060 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO NA 200401

    Patients

    Seq Age Sex Outcome Treatment
    1