BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CONFIANZA PTCA GUIDE WIRE

    MDR report key: 3112459 · Received May 14, 2013

    Report

    Report Number
    3003775027-2013-00021
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE HAS BEEN RECEIVED, BUT THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE GUIDE WIRE WAS RETURNED FOR EVALUATION. THE REPORTED UNRAVELED TIP COIL OF THE GUIDE WIRE WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. A QUERY OF THE COMPLAINT-HANDLING DATABASE INDICATED THERE ARE NO SIMILAR INCIDENTS REPORTED FROM THIS LOT FOR THIS DEFICIENCY. ADDITIONALLY, IT SHOULD BE NOTED THAT THE WARNING SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY IT MAY BREAK OR BECOME DAMAGED AND MAY RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. ADDITIONALLY, SEPARATION OR BREAKAGE OF THE GUIDE WIRE IS LISTED AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS IN THE IFU. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, AN ASAHI CONFIANZA 300 GUIDE WIRE WAS ADVANCED TO A CHRONIC TOTAL OCCLUSION (CTO) IN THE MODERATELY CALCIFIED LESION IN THE NON-TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD), FOLLOWED BY ADVANCEMENT OF A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) OVER THE CONFIANZA GUIDE WIRE WITHOUT RESISTANCE TO ASSIST THE CONFIANZA IN CROSSING PAST THE LESION. WITH THE BDC NOT YET ADVANCED INTO THE CTO, WHILE ATTEMPTING TO CROSS THE CTO WITH THE CONFIANZA GUIDE WIRE, THE GUIDE WIRE BECAME STUCK INSIDE OF THE CTO; IT WAS UNABLE TO BE ADVANCED OR RETRACTED DUE TO PATIENT ANATOMY. FORCE WAS APPLIED TO RETRACT THE CONFIANZA FROM THE CTO AND THE TIP COIL UNRAVELED. BOTH THE CONFIANZA AND MEDTRONIC BDC WERE WITHDRAWN AS A SINGLE UNIT WITHOUT FURTHER RESISTANCE FELT. ANOTHER ATTEMPT WAS MADE TO CROSS THE SAME CTO WITH ANOTHER ASAHI CONFIANZA 300 GUIDE WIRE, BUT THIS DEVICE WAS ALSO UNABLE TO CROSS THE CTO DUE TO PATIENT ANATOMY AND WAS WITHDRAWN WITHOUT ISSUE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TREATED WITH MEDICATION AS AN ALTERNATIVE TREATMENT. THERE WERE NO ADVERSE PATIENT EFFECTS, HOWEVER, THE SITE REPORTED THAT THE FIRST ASAHI CONFIANZA DEVICE CAUSED A CLINICALLY SIGNIFICANT DELAY; THERE WAS NO CLINICALLY SIGNIFICANT DELAY WITH THE 2ND ASAHI CONFIANZA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211994 ASAHI CONFIANZA PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 110309A051

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR