BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 16682236 · Received April 5, 2023

    Report

    Report Number
    9681834-2023-00068
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    February 7, 2023
    Report Date
    April 5, 2023
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: REQUESTED, UNKNOWN. AGE: REQUESTED, UNKNOWN. WEIGHT: REQUESTED, UNKNOWN. ETHNICITY: REQUESTED, UNKNOWN. RACE: REQUESTED, UNKNOWN. UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. HEALTH PROFESSIONAL: UNKNOWN. OCCUPATION: OTHERS PMA/510(K): K122590, K163004. THE ACTUAL SAMPLE ("THE GUIDEWIRE") WAS IN THE STATE COMBINED WITH A BALLOON CATHETER MADE BY ANOTHER COMPANY ("THE BALLOON CATHETER"). THE GUIDEWIRE COULD NOT BE PULLED OUT FROM THE BALLOON CATHETER. VISUAL INSPECTION OF BOTH DEVICES IN THE COMBINED STATE FOUND THAT THE DISTAL END OF THE GUIDEWIRE WAS FRACTURED. THE SHAFT OF THE BALLOON CATHETER HAD BEEN BUCKLED (IN THE AREA APPROXIMATELY 1035 MM - 1075 MM FROM ITS DISTAL END). MAGNIFYING INSPECTION OF BOTH DEVICES IN THE COMBINED STATE REGARDING THE AREA FROM THE DISTAL END OF THE GUIDEWIRE TO THE DISTAL END OF THE BALLOON CATHETER FOUND THAT THE OUTER LAYER HAD BEEN PEELED OFF FROM THE DISTAL END OF THE GUIDEWIRE, EXPOSING THE CORE WIRE FOR APPROXIMATELY 2 MM. THE COIL AT THE DISTAL END OF THE GUIDEWIRE HAD UNRAVELED AND FRACTURED. THERE WAS A BREAK IN THE OUTER LAYER AT THE DISTAL END OF THE GUIDEWIRE. THE OUTER LAYER IN THE VICINITY OF ITS BROKEN END HAD BEEN STRETCHED. REGARDING THE BALLOON CATHETER FOUND THAT THERE WERE NUMEROUS RED DEPOSITS IN THE BALLOON PART OF THE BALLOON CATHETER. IN THE BUCKLED SECTION, THERE WAS NO FLAW THAT COULD LEAD TO THE GENERATION OF BUCKLING. REGARDING THE AREA FROM THE PROXIMAL END OF BALLOON CATHETER TO THE PROXIMAL END OF GUIDEWIRE FOUND NO PEELING OR SCRATCHES OF OUTER LAYER ON THE PART OF THE GUIDEWIRE PROTRUDING FROM THE PROXIMAL END OF THE BALLOON CATHETER. ELECTRON MICROSCOPIC INSPECTION FOUND THAT THE SIDE OF THE DISTAL END OF CORE WIRE WAS IN THE SAME TAPERED SHAPE AS THAT OF A CURRENT PRODUCT SAMPLE. THE TOP SURFACE OF THE DISTAL END OF CORE WIRE SHOWED THE SAME TRACE OF PROCESSING DURING MANUFACTURING AS THAT OBSERVED ON THE CURRENT PRODUCT SAMPLE. FROM THIS, IT WAS INFERRED THAT THERE WAS NO PORTION MISSING FROM THE CORE WIRE. THE SIDE OF THE GOLD COIL WAS DEFORMED IN A TAPER SHAPE. THE BROKEN END OF THE OUTER LAYER SEEMED TO HAVE BEEN TORN OFF WITH MULTIPLE FLAWS ON THE SURFACE. FROM THIS, IT WAS INFERRED THAT THE OUTER LAYER AND THE GOLD COIL WERE EXPOSED TO PULLING LOAD WHILE THE DISTAL END OF THE GUIDEWIRE WAS IN CONTACT WITH A HARD OBJECT, WHICH RESULTED IN THE FRACTURED GOLD COIL AND TORN-OFF OUTER LAYER. X-RAY FLUOROSCOPIC INSPECTION FOUND THAT THE COIL AT THE DISTAL END OF GUIDEWIRE HAD BEEN STRETCHED. CLOGGING BY CONTRAST MEDIA WAS FOUND SCATTERING INSIDE THE BALLOON CATHETER. THE LUMEN AT THE BUCKLING PART OF THE BALLOON CATHETER WAS NARROW. THERE WAS RELATIVELY LESS CONTRAST MEDIA CLOGGING AT THE BUCKLING PART THAN AT THE OTHER SHAFT SECTION. THEREFORE, IT WAS PRESUMED THAT WHEN A COMPRESSIVE LOAD WAS APPLIED TO THE BALLOON CATHETER TO TRY TO RELEASE THE STICKING STATE, THE LOAD WAS CONCENTRATED IN THE AREA WHERE THERE WERE LESS CONTRAST MEDIA IN THE LUMEN, WHICH RESULTED IN THE BUCKLING. MAGNIFYING INSPECTION OF THE GUIDEWIRE SURFACE FOUND THAT THE BALLOON PORTION OF THE BALLOON CATHETER WAS DISASSEMBLED, AND THEN THE SURFACE OF THE STICKING GUIDEWIRE WAS VISUALLY INSPECTED. SOME DEPOSIT WAS OBSERVED. COMPONENT ANALYSIS OF THE DEPOSIT BY FT-IR* THE COLLECTED DEPOSIT HAD IR-SPECTRUM VERY SIMILAR TO THE PROTEIN MIXED WITH CONTRAST MEDIA. * FT-IR (FOURIER TRANSFORM INFRARED SPECTROSCOPY): AN ANALYSIS METHOD THAT IRRADIATES SUBSTANCES WITH INFRARED LIGHT AND MEASURES THE TRANSMITTED OR REFLECTED LIGHT FOR STRUCTURAL ANALYSIS AND QUANTITATIVE ANALYSIS. FROM THIS, IT WAS CONSIDERED THAT THE CLEARANCE BETWEEN THE GUIDEWIRE AND BALLOON CATHETER WAS REDUCED DUE TO THE SOLIDIFIED BLOOD AND CONTRAST MEDIA ON THE SURFACE OF THE GUIDEWIRE, WHICH RESULTED IN THE STICKING OF THE GUIDEWIRE. DIMENSIONAL INSPECTION FOUND THAT THE OUTER DIAMETER OF THE DISTAL END OF THE GUIDEWIRE (UNDAMAGED SECTION) MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. OUTER DIAMETER OF THE MAIN BODY OF THE GUIDEWIRE (UNDAMAGED SECTION) MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. HISTORY INVESTIGATION REGARDING THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION THAT THERE WAS NO ANOMALY IN THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD. THERE WAS NO OTHER SIMILAR REPORT FROM OTHER FACILITIES. ACCORDING TO THE INVESTIGATION RESULTS, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. [STICKING OF GUIDEWIRE] BASED ON THE DESCRIPTION OF THE EVENT AND THE RESULT OF INVESTIGATION, IT WAS INFERRED STICKING OCCURRED BY THE FOLLOWING MECHANISM IN THIS CASE. THE BALLOON CATHETER WAS INSERTED OVER THE GUIDEWIRE WITH SOLIDIFIED BLOOD AND CONTRAST MEDIA ADHERING TO THE GUIDEWIRE SURFACE DUE TO SOME FACTOR. THE CLEARANCE BETWEEN THE GUIDEWIRE AND BALLOON CATHETER BECAME SMALL AND THE BALLOON CATHETER BECAME STUCK ON THE GUIDEWIRE. WHEN PUSH AND PULL MANIPULATION WAS PERFORMED TO THE BALLOON CATHETER FOR THE RELEASE OF STICKING STATE, A COMPRESSIVE LOAD WAS APPLIED TO THE BALLOON CATHETER AND THE SHAFT PORTION BUCKLED. THIS MADE THE INNER DIAMETER NARROWER AND PROMOTED THE STICKING STATE. [FRACTURE OF GUIDEWIRE] BASED ON THE DESCRIPTION OF THE EVENT AND THE RESULT OF INVESTIGATION, IT WAS INFERRED THAT THE OUTER LAYER AND THE GOLD COIL WERE EXPOSED TO PULLING LOAD WHILE THE DISTAL END OF THE GUIDEWIRE WAS IN CONTACT WITH A HARD OBJECT (E.G., HIGHLY CALCIFIED LESION), WHICH RESULTED IN THE FRACTURED GOLD COIL AND TORN-OFF OUTER LAYER. HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE CLEARLY WHEN THE FRACTURE/TEARING OCCURRED. AS THE OUTER LAYER AND THE COIL HAD BEEN STRETCHED, THE RESPECTIVE MISSING LENGTHS COULD NOT BE CLARIFIED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE ADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIRE ADVANTAGE OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO PROVIDE CORRECTIONS TO SECTION D3.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE GLIDEWIRE INVOLVED WAS BLOCKED. THE ACCESS WAS VIA THE LEFT FEMORAL ARTERY WITH AN ANTEGRADE PUNCTURE, THEN THE 6 FRENCH SHEATH WAS INSERTED. THE GLIDEWIRE ADVANTAGE 18/300 WAS USED AND, THEN A PASSEO 18 3/200 (BALLOON) WAS ADVANCED. THE BALLOON GOT STUCK ON THE WIRE AND COULD NOT BE MOVED FORWARD OR BACKWARD. BOTH DEVICES WERE REMOVED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211783 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA N/A 220906

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Female GLIDEWIRE ADVANTAGE 18/300.| PASSEO 18 3/200 (BALLOON).