BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGALIA XS 1.0

    MDR report key: 11320337 · Received February 12, 2021

    Report

    Report Number
    3003775027-2021-00030
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    January 25, 2021
    Report Date
    January 25, 2021
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04547327131094
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE: ASAHI INTECC ((B)(4)) CO., LTD., (B)(4), REGISTRATION NUMBER: (B)(4). THE REGALIA XS 1.0 GUIDE WIRE WAS RETURNED FOR EVALUATION. THE RETURNED GUIDE WIRE HAD ITS COIL FRACTURED AND ELONGATED FOR APPROXIMATELY 850MM FROM THE PROXIMAL SOLDER ORIGINALLY LOCATED AT 120MM FROM THE TIP. THE POLYMER JACKET COVERING THE COIL WAS ALSO STRETCHED FROM THE PROXIMAL SOLDER AND ITS TORN FRAGMENTS REMAINED ON THE ELONGATED COIL. HELICAL DEFORMATION WAS FOUND AROUND THE PROXIMAL SOLDER; THE FRACTURED CORE WAS LOCATED AT THE DISTAL END OF THE DEFORMED SEGMENT. MICROSCOPIC OBSERVATION ON THE CORE FOUND THAT THERE WAS SOLDERED FILLER METAL ON THE FRACTURE END OF THE CORE. THE FRACTURE END OF THE ELONGATED COIL WAS STRAIGHTENED WHERE SOLDERED FILLER METAL WAS ALSO OBSERVED. FURTHER OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) REVEALED THAT THE FRACTURE END OF THE CORE WAS NECKED AND DIMPLES WERE ON THE FRACTURE SURFACE OF THE CORE. THE FRACTURE END OF THE COIL WAS ALSO NECKED. THESE FINDINGS INDICATED THAT TENSILE STRESS HAD CONTRIBUTED TO FRACTURE OF BOTH CORE AND COIL. MEASUREMENT OF THE RETURNED GUIDE WIRE SUGGESTED THAT APPROXIMATELY 25MM OF THE TIP SEGMENT INCLUDING CORE AND COIL WAS NOT RETURNED. IT WAS UNABLE TO IDENTIFY HOW MUCH OF THE POLYMER JACKET WAS MISSING. 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 TENSILE STRESS GENERATED WITH REMOVAL HAD MOST LIKELY CONTRIBUTED TO THE OBSERVED SEPARATION OF THE RETURNED REGALIA XS 1.0 GUIDE WIRE. THE APPLIED STRESS WOULD EXCEED THE PRODUCT DESIGN LIMIT WHEN THE TIP WAS BEING CAUGHT AND RESTRICTED ITS MOVEMENT BY THE CTO. FURTHER APPLIED TENSILE STRESS MADE THE COIL AND THE POLYMER JACKET ELONGATE AND EVENTUALLY SEPARATE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. BECAUSE THE SEPARATED TIP WAS NOT RETURNED, IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY THAT A PORTION OF IT MIGHT BE LEFT IN THE PATIENT. 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. 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. 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. [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OF THE GUIDE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF AN ASAHI REGALIA XS 1.0 GUIDE WIRE BECAME SEPARATED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE ANTERIOR TIBIAL ARTERY. IT WAS DIFFICULT TO CROSS THE CTO WITH THE GUIDE WIRE. THE PHYSICIAN KNUCKLED THE GUIDE WIRE IN ATTEMPTS TO CROSS WHEN THE WIRE TIP GOT TRAPPED IN THE CTO. UPON ATTEMPTS TO REMOVE THE STUCK GUIDE WIRE, THE TIP DETACHED FROM ITS BODY. ANOTHER GUIDE WIRE WAS ADVANCED IN AN ATTEMPT TO RETRIEVE THE SEPARATED TIP; HOWEVER, THE ATTEMPT FAILED. IT WAS SURGICALLY REMOVED. THE PHYSICIAN COMMENTED THAT HE HAD FORCEFULLY REMOVED THE GUIDE WIRE AND THUS IT CAUSED THE GUIDE WIRE TO FRACTURE. THE LESION ITSELF WAS SUCCESSFULLY REESTABLISHED. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219382 REGALIA XS 1.0 PERIPHERAL GUIDE WIRE DQX ASAHI INTECC CO., LTD. NA 200523A491 04547327131094

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R