BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JINDO STEERABLE GUIDEWIRE

    MDR report key: 3190461 · Received June 26, 2013

    Report

    Report Number
    1016427-2013-00087
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 7, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K974560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10059540. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2013-00088.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED BY AN AFFILIATE, TWO JINDO WIRES KINKED AND UNRAVELED AT THE DISTAL PORTION OF THE DEVICE. A THIRD JINDO WAS USED WITH NO ISSUES. THERE WAS NO PATIENT INJURY. THE DEVICES WERE STORED, PREPPED AND INSPECTED PER INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING IT IN THE PATIENT. BRACHIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. THERE WAS DIFFICULTY INSERTING A GUIDING CATHETER (SHEATHLESS PV) INTO THE ARTERY. A JINDO (180CM SHORT) LOT# 71011436 WIRE WAS INSERTED AS BACK UP. HOWEVER, THE JINDO TOOK TOO MUCH TIME TO CROSS THE LESION. THE JINDO SEEMED TO BE DEFORMED UNDER THE X-RAY. THEREFORE, THE JINDO WAS RETRIEVED FROM THE PATIENT AND WAS CONFIRMED TO BE BENT AT APPROXIMATELY 2CM FROM ITS DISTAL END OUTSIDE THE PATIENT AND IT'S DISTAL PORTION SEEMED TO BE UNRAVELED. THEREFORE, A NEW JINDO (180CM SHORT) LOT# 71011436 WAS USED BUT THE SAME EVENT OCCURRED. NO EXCESSIVE FORCE WAS USED DURING INSERTION. THEN, A THIRD NEW JINDO WAS USED AND CROSSED THE LESION WITH NO ISSUES. THE PROCEDURE WAS FINISHED AFTER A TREATMENT FOR THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION WAS THE RIGHT COMMON ILIAC ARTERY. IT IS UNKNOWN IF THE LESION WAS A DE NOVO, BUT WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THE COMMON ILIAC ARTIER WAS 90% STENOSED. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. (B)(4): ONE NON-STERILE PGW JINDO 180CM STR .035 WAS RECEIVED COILED INTO A PLASTIC BAG. THE GUIDEWIRE PRESENTED NO VISUAL DAMAGE. THE DISTAL TIP PRESENTED AN UNRAVELED/STRETCHED AND KINKED CONDITION AT THE DISTAL END. THE DISTAL TIP WAS INSPECTED UNDER MICROSCOPE AND THE DAMAGES WERE CONFIRMED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿DISTAL TIP - UNRAVELED/STRETCHED¿ AND ¿DISTAL TIP - KINKED/BENT¿ WAS CONFIRMED DURING ANALYSIS OF THE ONE PRODUCT THAT WAS RETURNED. THE CAUSE OF THE UNRAVELED/STRETCHED AND THE KINKED CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT REPORTED DURING PROCEDURE. THE FAILURE TO CROSS COULD NOT BE CONFIRMED DUE TO THE NATURE OF THE EVENT; HOWEVER, VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT (CALCIFICATION, TORTUOSITY). THE FLEXIBLE, "DELICATE" NATURE OF THE "FLOPPY" TIP CONFIGURATION REQUIRES DUE CARE IN HANDLING AND USE, AS DIRECTED IN THE DEVICE INSTRUCTIONS FOR USE (IFU). TIP FRACTURES HAVE BEEN REPORTED IN PROCEDURES INVOLVING GUIDEWIRE ENTRAPMENT, TOTAL OCCLUSIONS, HIGHLY TORTUOUS VASCULATURE, AND SMALL SIDE BRANCHES. THE IFU WARNS TO "NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS RESISTANCE. FIRST, USING FLUOROSCOPY, DETERMINE THE CAUSE OF RESISTANCE AND TAKE ANY NECESSARY REMEDIAL ACTION. TORQUING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE, AND/OR GUIDEWIRE TIP SEPARATION, OR DIRECT DAMAGE TO THE VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED (VIA FLUOROSCOPY) BY NOTING ANY BUCKLING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR¿. IN ADDITION, "IF ANY RESISTANCE IS FELT (I.E., DUE TO VESSEL SPASM, BENT GUIDEWIRE, OR GUIDEWIRE ENTRAPMENT) WHILE MANIPULATING OR REMOVING THE GUIDEWIRE IN THE BLOOD VESSEL: STOP THE PROCEDURE. DO NOT MOVE OR TORQUE THE GUIDEWIRE. USING FLUOROSCOPY, FIRST DETERMINE THE CAUSE OF THE RESISTANCE, THEN TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED. THIS MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE GUIDEWIRE MANUFACTURING PROCESS, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, TWO JINDO WIRES KINKED AND UNRAVELED AT THE DISTAL PORTION OF THE DEVICE. A THIRD JINDO WAS USED WITH NO ISSUES. THERE WAS NO PATIENT INJURY. THE DEVICES WERE STORED, PREPPED AND INSPECTED PER IFU INSTRUCTIONS. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING IT IN THE PATIENT. BRACHIAL APPROACH WAS CHOSEN FOR THE PROCEDURE. THERE WAS DIFFICULTY INSERTING A GUIDING CATHETER (SHEATHLESS PV) INTO THE ARTERY. A JINDO (180CM SHORT) LOT# 71011436 WIRE WAS INSERTED AS BACK UP. HOWEVER, THE JINDO TOOK TOO MUCH TIME TO CROSS THE LESION. THE JINDO SEEMED TO BE DEFORMED UNDER THE X-RAY. THEREFORE, THE JINDO WAS RETRIEVED FROM THE PATIENT AND WAS CONFIRMED TO BE BENT AT APPROXIMATELY 2CM FROM ITS DISTAL END OUTSIDE THE PATIENT AND ITS DISTAL PORTION SEEMED TO BE UNRAVELED. THEREFORE, A NEW JINDO (180CM SHORT) LOT# 71011436 WAS USED BUT THE SAME EVENT OCCURRED. NO EXCESSIVE FORCE WAS USED DURING INSERTION. THEN, A THIRD NEW JINDO WAS USED AND CROSSED THE LESION WITH NO ISSUES. THE PROCEDURE WAS FINISHED AFTER A TREATMENT FOR THE SUPERFICIAL FEMORAL ARTERY. THE TARGET LESION WAS THE RIGHT COMMON ILIAC ARTERY. IT IS UNKNOWN IF THE LESION WAS A DE NOVO, BUT WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. THE % OF THE STENOSIS WAS 90%. STENT PLACEMENT TO THE CIA. ONE OF THE PRODUCTS WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289962 JINDO STEERABLE GUIDEWIRE ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 71011436

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR