BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER EXIMO ATHERECTOMY

    MDR report key: 15374525 · Received September 7, 2022

    Report

    Report Number
    1319211-2022-10008
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 22, 2022
    Report Date
    September 20, 2022
    Manufacturer
    EXIMO MEDICAL LTD.
    Product Code
    MCW
    PMA / PMN Number
    K181642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF INNER BLADE DETACHED FROM THE TIP WAS PARTIALLY CONFIRMED. THE INNER BLADE WAS HANGING OF THE DISTAL TIP BUT WAS NOT COMPLETELY DETACHED FROM THE CATHETER. A REVIEW OF THE DISTRIBUTION RECORDS WAS PERFORMED FOR THE REPORTED CATHETER SERIAL NUMBER (B)(6) FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE CATHETER MET ALL PACKAGING PERFORMANCE SPECIFICATIONS, I.E. NO NCR WRITTEN. THE COMPLAINT EVENT WAS FORWARDED TO THE LASER CATHETER MANUFACTURER (EXIMO). EXIMO PERFORMED A DHR REVIEW OF THE REPORTED CATHETER SERIAL NUMBER (B)(6) . THE REVIEW CONFIRMED THAT THE CATHETER MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS, E.G., NO MANUFACTURING NON-CONFORMANCE REPORTS WERE ISSUED. THERE HAVE BEEN NO PREVIOUSLY REPORTED COMPLAINTS FOR THE INDICATED CATHETER LOT NUMBER FOR SIMILAR FAILURE MODES. AN AGILE COMPLAINT SEARCH FOR THE ATHERECTOMY DISPOSABLES (CATHETER) PRODUCT FAMILY FOR THE FAILURE MODE (OCCURRENCES) "CATHETER, UNABLE TO ADVANCE": JUNE - 0, JULY - 0, AND AUGUST - 1. THIS DOES NOT CONSTITUTE AN ADVERSE TREND. AN AGILE COMPLAINT SEARCH FOR THE ATHERECTOMY DISPOSABLES (CATHETER) PRODUCT FAMILY FOR THE FAILURE MODE (OCCURRENCES) "TIP, DETACHED/SEPARATED/FRACTURED": JUNE - 0, JULY - 0, AND AUGUST -2. THIS DOES NOT CONSTITUTE AN ADVERSE TREND. AN AGILE COMPLAINT SEARCH FOR THE ATHERECTOMY DISPOSABLES (CATHETER) PRODUCT FAMILY FOR THE FAILURE MODE (OCCURRENCES) "TIP, DAMAGED": JUNE - 0, JULY - 1, AND AUGUST - 0. THIS DOES NOT CONSTITUTE AN ADVERSE TREND. RISK MANAGEMENT REVIEW: FMEA/RISK ASSESSMENT REFERENCE DOCUMENT: EXIMO SYSTEM RISK ANALYSIS, DOCUMENT NUMBER RSA0100, REV. 28 [REFERENCE P017451, REV. E], INDEX NO. 16 (AURYON BENT/BREAKAGE INSIDE THE VESSEL TRACT). SEVERITY RATING (FROM RISK ANALYSIS): 2 - MODERATE PROBABILITY OCCURRENCE RATING (FROM RISK ANALYSIS): 4 - PROBABLE (1.0 TO 10.0%), [10,001-100,000 PPM] ACTUAL PPM: 0.0030% [30.0 PPM] (1 OCCURRENCE FOR AURYON CATHETER, "DETACHED/SEPARATED/FRACTURED" / (B)(4) UNITS SOLD [LAST 15 MONTHS] PER JULY 2022 COMPLAINT REPORT AND AGILE COMPLAINT SEARCH). THIS FREQUENCY INCLUDES THE OCCURRENCE REPORTED PER COMPLAINT (B)(4). PROBABILITY OCCURRENCE RATING (ACTUAL): 2 - REMOTE (0.001 TO 0.01%), [11-100 PPM]. THE ACTUAL PROBABILITY OCCURRENCE RATING IS WITHIN THE EXPECTED PROBABILITY OCCURRENCE RATING LISTED IN THE RISK DOCUMENTATION. LABELING REVIEW: INSTRUCTIONS FOR USE (IFU0100) IS PROVIDED WITH THE CATHETER DEVICE AND CONTAIN THE FOLLOWING STATEMENTS: WARNINGS: - PAY CAREFUL ATTENTION WHILE USING THE CATHETER, AVOID EXCESSIVE FORCE AND BE ON ALERT FOR ANY POTENTIAL DAMAGE. INADVERTENT MOVEMENT OF THE CATHETER MAY RESULT IN PATIENT INJURY. - ALWAYS USE FLUOROSCOPIC SURVEILLANCE WHEN ADVANCING THE AURYON CATHETER INSIDE THE PATIENT VASCULATURE TO AVOID MISPLACEMENT, DISSECTION, OR PERFORATION. AURYON CATHETER INSERTION OVER THE WIRE UNTIL LASER ACTIVATION: YOU MAY USE ANY OTHER GW TO CROSS THE LESION, BUT THE FINAL GW THAT AURYON CATHETERS WILL TRACK OVER SHOULD BE 300CM 0.014", AND PREFERABLY STIFF GWS. ONCE THIS GW IS ANGIOGRAPHICALLY VERIFIED TO CROSS THE LESION IN THE VESSEL'S LUMEN, IT IS READY FOR AURYON CATHETER INSERTION OVER THE WIRE. ADVANCEMENT OF AURYON CATHETER THROUGH THE LESION: A) DO NOT TO EXCEED 10 SECONDS OF LASING AT THE SAME LOCATION. IF YOU EXPERIENCE ANY DIFFICULTY TO ADVANCE THE AURYON CATHETER, IMMEDIATELY START SELF-COUNT-DOWN. SELF-COUNT-DOWN SHOULD START THE MOMENT YOU EXPERIENCE NON-ADVANCEMENT OF THE AURYON CATHETER. WHEN ADVANCEMENT RESUMES, YOU SHOULD STOP SELF-COUNT-DOWN AND RESUME IT IF ADDITIONAL NON-ADVANCEMENTS ARE EXPERIENCED. B) IF THE AURYON CATHETER CANNOT BE ADVANCED BY THE 10TH SECOND OF LASER ACTIVATION, YOU SHOULD RELEASE THE FOOT SWITCH TO STOP THE LASER, RETRACT THE CATHETER APPROXIMATELY 3-4 MM, AND TRY TO ADVANCE AGAIN WHILE ROTATING THE CATHETER SHAFT APPROXIMATELY 90 DEGREES TO EITHER SIDE, WHILE RESUMING 10 SECONDS COUNT DOWN. C) IF THE AURYON CATHETER IS STILL NOT ADVANCING WITH THE ABOVE-MENTIONED ROTATION MANIPULATION FOR THE ADDITIONAL 10-SECONDS, IMMEDIATELY STOP THE LASER ACTIVITY BY RELEASING THE FOOTSWITCH. D) ASK THE LASER OPERATOR TO RAISE THE FLUENCE TO THE 60MJ/MM2. E) ACTIVATE THE LASER AND TRY AGAIN TO ADVANCE THE AURYON CATHETER THROUGH THE LESION. F) IF THE AURYON CATHETER CANNOT BE ADVANCED, RESUME THE SELF-COUNT-DOWN TO 10 SECONDS. G) IF THE AURYON CATHETER CANNOT BE ADVANCED IN THIS ATTEMPT, STOP THE LASER ACTIVITY, WITHDRAW THE AURYON CATHETER, AND USE A NEW CATHETER. THERE ARE SEVERAL POTENTIAL ROOT CAUSES - - ADDITIONAL TENSION THAT THE PHYSICIAN GIVES TO THE CATHETER MAY HAVE RESULTED IN EXCESSIVE FORCE AND A HIGHER FIBER'S DEGRADATION RATE. - THE CATHETER WAS WORKING FOR THE MAXIMALLY ALLOWED DURATION AT ITS HIGHEST ENERGY OF 60MJ/MM2, WHICH CAN ALSO RESULT IN A HIGHER FIBER'S DEGRADATION RATE. IT SHOULD BE NOTED THAT THE INNER BLADE IS WELDED TO THE GW TUBE AND GLUED TO THE INNER GW BRAIDED TUBE- HENCE, IT IS NOT EXPECTED FOR THIS COMPONENT TO COMPLETELY SEPARATE FROM THE CATHETER. NO MANUFACTURING NON-CONFORMANCE WAS OBSERVED DURING THE SAMPLE EVALUATION. THE DHR WAS REVIEWED FOR THE INDICATED CATHETER LOT NUMBER. THE REVIEW CONFIRMED THAT THE LOT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS, E.G., NO MANUFACTURING NON-CONFORMANCE REPORTS WERE ISSUED. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED AN ISSUE WITH A 2MM EXIMO ATHERECTOMY CATHETER. A 6FR TERUMO PRECISION ANTEGRADE SHEATH AND A COMMAND WIRE WERE CHOSEN AND A 2MM CATHETER WAS SELECTED DUE TO ISR AND MIXED PLAQUE MORPHOLOGY. DURING THE PROCEDURE, THE CATHETER GOT TO AN ECCENTRIC CALCIFIED LESION AND WOULD NOT ADVANCE; THEREFORE, THE PHYSICIAN GAVE TENSION ON THE WIRE, FROM THE RETROGRADE SHEATH, BUT THE DEVICE STILL WOULD NOT ADVANCE. THE DEVICE WAS REMOVED AND THE INNER BLADE AND WIRE PORT WERE FOUND TO BE DETACHED FROM THE CATHETER. A NEW 2.0 CATHETER WAS THEN REINSERTED AND THE CASE WAS FINISHED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107535 CATHETER EXIMO ATHERECTOMY PERIPHERAL ATHERECTOMY CATHETER MCW EXIMO MEDICAL LTD. 61933

    Patients

    Seq Age Sex Outcome Treatment
    1 Male