BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SION BLUE

    MDR report key: 20061081 · Received August 25, 2024

    Report

    Report Number
    3003775027-2024-00082
    Event Type
    Injury
    Date Received
    August 25, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K191464
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. AS THE INFORMATION IN THIS REPORT WAS ENTIRELY BASED ON LITERATURE, WHICH DID NOT PROVIDE SUCH DETAILED DEVICE INFORMATION AS LOT NUMBER OR UNIQUE DEVICE IDENTIFIER (UDI), NO OTHER INFORMATION THAN THE BRAND NAME COULD BE OBTAINED. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICES WERE DISCARDED AND NOT RETURNED FROM THE USER FACILITY. LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS AND SATISFIED THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. BASED ON THE LITERATURE INFORMATION AND REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT STRESS EXCEEDING THE PRODUCT DESIGN LIMIT MIGHT HAVE BEEN APPLIED AS WITHDRAWAL MANIPULATION CONTINUED WHILE THE SUBJECT SION BLUE GUIDE WIRE HAD BEEN CAUGHT IN THE DEPLOYED STENT, RESTRICTING THE GUIDE WIRE MOVEMENT. CONSEQUENTLY, THE DISTAL SEGMENT OF THE GUIDE WIRE WAS FRACTURED AND DETACHED. ALTHOUGH IT WAS CONCLUDED THAT THE REPORTED EVENTS WERE NOT ATTRIBUTED TO PRODUCT QUALITY, REMOVAL OF THE WIRE FRAGMENT WITH ANOTHER WIRE WAS CONSIDERED AS AN ADDITIONAL TREATMENT. IT WAS ALSO CONCLUDED THAT POSSIBILITY COULD NOT BE COMPLETELY RULED OUT THAT A FRAGMENT MIGHT BE LEFT IN SITU SHOULD THE SAME EVENT RECUR. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. 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, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. DO NOT PERFORM STENT PLACEMENT USING MORE THAN ONE GUIDE WIRE OR WIRE OPERATION THROUGH STENT STRUT. OTHERWISE, THE STENT MAY BE DAMAGED OR THE GUIDE WIRE MAY BREAK OR BREAK APART. [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITERATURE THAT AN ASAHI SION BLUE GUIDE WIRE WAS ENTANGLED WITH A STENT, FRACTURED, AND LEFT IN THE LEFT IN THE LEFT MAIN ARTERY (LM) AND PROXIMAL LAD OF A PATIENT, REQUIRING AN ADDITIONAL TREATMENT. PUBLICATION: A EUROPEAN HEART JOURNAL - CASE REPORTS (2023) 7, 1-7 TITLE: SAFE AND PREDICTABLE TRANSCATHETER REMOVAL OF BROKEN CORONARY GUIDEWIRES: THE 'KNUCKLE-TWISTER' TECHNIQUE: A CASE SERIES REPORT EXCERPT IS AS FOLLOWS: CASE 4: THE PATIENT HAD TYPICAL ANGINA AT REST AND ANTERIOR WALL ISCHAEMIA DETECTED DURING STRESS CARDIAC MAGNETIC RESONANCE TESTING. CORONARY ANGIOGRAPHY FOUND A TRUE BIFURCATION LESION AT THE D1 SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DOUBLE KISSING CULOTTE (DK-CULOTTE) TECHNIQUE WITH TWO STENTS WAS PERFORMED USING TWO ASAHI SION BLUE GUIDE WIRES. DURING REWIRING THROUGH TWO LAYERS OF STRUTS FOR THE FINAL KISSING BALLON INFLATION (KBI), THE SION BLUE GUIDE WIRE ADVANCED WITH SIGNIFICANT FRICTION TOWARDS D1 AND GOT ENTRAPPED WHEN PULLING BACK. IT WAS INFORMED THAT THE FIRST KISSING BALLOON INFLATION DID NOT EXPAND FULLY UP TO THE SIDE-BRANCH STENT (D1), LEAVING IT UNDER EXPANDED AND MOST PROBABLY CONTRIBUTING TO THE WIRE ENTRAPMENT. THE DETACHED WIRE FRAGMENT WAS SUCCESSFULLY AND SAFELY RETRIEVED USING THE 'KNUCKLE-TWISTER' TECHNIQUE, ON FIRST ATTEMPT. THE PROCEDURE WAS FINALIZED WITH A GOOD ANGIOGRAPHIC RESULT, AND THE PATIENT REMAINED UNEVENTFUL AT 1-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245633 ASAHI SION BLUE PTCA GUIDE WIRE DQX ASAHI INTECC CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| O