BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CONQUEST PRO 9-40

    MDR report key: 5610792 · Received April 27, 2016

    Report

    Report Number
    3003775027-2016-00066
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    April 6, 2016
    Report Date
    September 23, 2016
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS REPORT IS SOLD ONLY OUTSIDE THE USA, BUT IS SIMILAR IN STRUCTURE AND CONSTRUCTION AS A CURRENTLY MARKETED DEVICE, ASTATO XS 40 (K153443), THOUGH THE INDICATIONS FOR USE ARE DIFFERENT. THE REPORTED EVENT IS RELATED TO THE USE OF THE GUIDEWIRE IN A CORONARY APPLICATION, WHEREAS THE US MARKETED DEVICE IS CLEARED FOR PERIPHERAL APPLICATIONS ONLY. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT. INVESTIGATION OF RETURNED DEVICES REVEALED THAT THE GUIDEWIRE WAS INSERTED THROUGH THE MICROCATHETER, ELONGATED DISTAL END OF THE COIL WAS EXTRUDED OUT FROM THE DISTAL END OF THE MICROCATHETER. THE MICROCATHETER WAS FOUND TO BE PIERCED BY A WIRE, SUPPOSED TO BE THE CORE WIRE OF THE GUIDEWIRE, AT 22MM FROM TIP END. THE WIRE WAS EXTRUDED FROM THE CATHETER WALL. UPON REMOVAL OF THE GUIDEWIRE FROM THE MICROCATHETER, THE GUIDEWIRE WAS THOUGHT TO BE IN ONE UNIT WITHOUT SEPARATION UP TO THE END OF THE GUIDEWIRE THOUGH ITS COIL WAS ELONGATED, HOWEVER THE WIRE ON THE CATHETER WALL REMAINED WITH THE CATHETER. UPON REMOVAL OF THE WIRE FROM THE CATHETER WALL, IT WAS FOUND TO BE A BROKEN FRAGMENT WITH 30MM LENGTH. CLOSE INVESTIGATION OF THE CORE WIRE OF THE GUIDEWIRE REVEALED THAT IT WAS BROKEN IN TO 3 PIECES, DISTAL 38MM (WITH THE COIL WIRE DISTAL END, A BEND FOUND AT TIP 13MM), MIDDLE 30MM(PIERCING THE CATHETER WALL), AND THE PROXIMAL PORTION WITH THE SHAFT, TOTAL LENGTH OF THE CORE WIRE FRAGMENTS WAS CONFIRMED TO BE MEETING THE ORIGINAL LENGTH OF THE PRODUCT. CLOSE OBSERVATION OF THE BREAKAGE SITES SHOWED THE TRACE OF BREAKAGE DUE TO REPEATED BENDING FORCE. LOT HISTORY REVIEW REVEALED NO ANOMALY WITH THIS LOT PRODUCTS. NO OTHER EVENT WAS REPORTED FOR THIS LOT. ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. BASED ON THE OBTAINED INFORMATION AND THE OUTCOMES OF THE INVESTIGATION OF THE RETURNED DEVICES, IT WAS INFERRED THAT GUIDEWIRE WAS EXPOSED TO REPEATED BENDING FORCE DURING THE ATTEMPT OF CROSSING THE LESION, WHICH RESULTED THE FIRST BREAKAGE OF CORE WIRE. AFTER SOME PULL BACK OF THE GUIDEWIRE, ADVANCEMENT OF THE GUIDEWIRE WAS MADE, WHICH LED THE PIERCING EVENT TO THE MICROCATHETER AT THE POINT WHERE THE CATHETER SHAFT WAS BENT, FURTHER MANIPULATION TO THE GUIDEWIRE LED SECOND BREAKAGE TO THE CORE WIRE OF THE GUIDEWIRE, THE BROKEN MIDDLE FRAGMENT OF THE CORE WIRE WAS LEFT ATTACHED TO THE CATHETER WALL, OTHER PORTION OF THE GUIDEWIRE INCLUDING THE COIL WIRE OF NO BREAKAGE WERE REMOVED OUT WITH THE MICROCATHETER. THE BREAKAGE OF THE CORE WIRE IS DEEMED TO BE DUE TO REPEATED BENDING FORCE GIVEN TO THE GUIDEWIRE, WHICH WAS ACCUMULATED TO THE CORE WIRE AND FINALLY EXCEEDED THE PRODUCT DESIGN LIMIT. IFU DESCRIBES IN ITS WARNING; IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDEWIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDEWIRE ITSELF. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY IT MAY BREAK OR BECOME DAMAGED. WHEN TORQUING THIS GUIDEWIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDEWIRE TO BE DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDEWIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATIVELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREE) IN THE SAME DIRECTION.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    REPORTEDLY IN THE PROCEDURE TO HEAVILY CALCIFIED CTO LESION AT RCA, SEVERAL GUIDEWIRES FAILED TO REACH TO OR CROSS THE LESION VIA RETROGRADE AND/OR ANTEGRADE APPROACH. THEN THE SUBJECT GUIDEWIRE WAS ADVANCED WITH A MICROCATHETER SUPPORTING, HOWEVER, PHYSICIAN NOTICED THAT THE GUIDEWIRE TIP HAD PIECED THE MICROCATHETER. THERE WAS NO INJURY OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268047 ASAHI CONQUEST PRO 9-40 PTCA GUIDEWIRE DQX ASAHI INTECC CO., LTD. NA 151123A22A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR