BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLADIUS MG 14 PV

    MDR report key: 11137492 · Received January 7, 2021

    Report

    Report Number
    3003775027-2020-00194
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    November 9, 2020
    Report Date
    November 11, 2020
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    PMA / PMN Number
    K150445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE BASED ON MANUFACTURING RECORDS RECEIVED ON JAN15, 2021. CORRECTED G4 510(K) # THAT WAS OMITTED IN INITIAL REPORT. MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: ASAHI INTECC (B)(4). THE GLADIUS MG 14 PV GUIDE WIRE WITH A COIL FRAGMENT WAS RETURNED FOR EVALUATION. THE COIL WIRE AND THE POLYMER JACKET WERE FOUND STRETCHED AT APPROXIMATELY 26MM DISTAL TO THE PROXIMAL SOLDER LOCATED AT 85MM FROM THE TIP. THE COIL WIRE WAS FRACTURED AND THE POLYMER JACKET WAS TORN AT APPROXIMATELY 40MM FROM THE PROXIMAL SOLDER. THE CORE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 50MM DISTAL TO THE PROXIMAL SOLDER. OBSERVATION UNDER A SCANNING ELECTRON MICROSCOPE (SEM) FOUND DIMPLES IN A CONCENTRIC PATTERN ON THE FLAT FRACTURE SURFACE OF THE CORE WIRE, WHICH WAS A TRACE OF FRACTURE DUE TO ACCUMULATION OF ROTATIONAL FORCE. THE FRACTURE END OF THE COIL WIRE WAS FOUND WITH TORSIONAL PATTERS IN ONE DIRECTION ON THE FLAT SURFACE, WHICH WAS A TRACE OF TORSIONAL FORCE ATTRIBUTED TO STRETCHING A HELICAL STRUCTURE. THE RETURNED COIL FRAGMENT WAS FOUND WITH A POLYMER JACKET FRAGMENT REMAINED ON IT. THE COIL WIRE WAS STRETCHED TO APPROXIMATELY 220MM IN LENGTH AND FRACTURED. SEM OBSERVATION OF EACH OF THE FRACTURE ENDS FOUND DIMPLES ALIGNED IN ONE DIRECTION ON THE FLAT SURFACE, WHICH WAS A TRACE OF TORSIONAL FORCE ATTRIBUTED TO STRETCHING A HELICAL STRUCTURE. MEASUREMENT OF THE RETURNED GLADIUS MG 14 PV FOUND THAT APPROXIMATELY 35MM OF THE DISTAL SEGMENT INCLUDING THE INNER COIL WIRE WAS DETACHED. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT ROTATIONAL FORCE WAS LOCALLY ACCUMULATED DUE TO GUIDE WIRE MANIPULATION WHILE THE DISTAL SEGMENT OF THE SUBJECT GLADIUS MG 14 PV WAS TRAPPED, CAUSING THE CORE WIRE TO BE FRACTURED. AS PULLING FORCE WAS APPLIED, THE POLYMER JACKET AND THE COIL WIRE WERE STRETCHED AND FRACTURED, CAUSING THE INNER COIL WIRE TO BE FRACTURED AS WELL. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. THE INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING A GUIDE WIRE AGAINST RESISTANCE MAY CAUSE GUIDE WIRE DAMAGE AND/OR GUIDE WIRE TIP SEPARATION OR DIRECT DAMAGE TO A VESSEL; [WARNINGS] 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, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL; [WARNINGS] WHEN TORQUING THIS GUIDE WIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDE WIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720?¿) IN THE SAME DIRECTION; AND, [MALFUNCTIONS AND ADVERSE EFFECTS] SEPARATION OR BREAKAGE OF THE GUIDE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATTEMPTS WERE MADE TO ANTEGRADELY CROSS A CTO IN THE RIGHT ANTERIOR TIBIAL ARTERY (ATA) WITH A GUIDE WIRE DURING PPI. AS THE GUIDE WIRE DID NOT CROSS, AN ATTEMPT WAS MADE WITH AN ASAHI GLADIUS MG 14 PV GUIDE WIRE TO CROSS THE LESION BY THE KNUCKLE WIRE TECHNIQUE UNDER SUPPORT OF A NON-ASAHI MICROCATHETER. THE DISTAL SEGMENT OF THE GLADIUS MG 14 PV GOT STUCK IN A FALSE LUMEN. THE GUIDE WIRE WAS PULLED BUT COULD NOT BE WITHDRAWN. WHEN THE GUIDE WIRE WAS TUGGED, THE DISTAL SEGMENT WAS SEPARATED. ATTEMPTS WERE MADE TO SNARE THE FRAGMENT BUT FAILED. ALTHOUGH THE PROCEDURE WAS CONTINUED, NO OTHER GUIDE WIRES COULD CROSS THE LESION. THE PROCEDURE WAS DISCONTINUED. THE PHYSICIAN COMMENTED THAT THE TIP OF THE GUIDE WIRE MIGHT BE TRAPPED BY THE CALCIUM. IT WAS INFORMED THAT THE PATIENT WAS IN THE HOSPITAL FOR AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31638 GLADIUS MG 14 PV PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 200312A271

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention| S