BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASSALLO GT

    MDR report key: 17640052 · Received August 29, 2023

    Report

    Report Number
    3012223769-2023-00002
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    July 28, 2023
    Report Date
    August 29, 2023
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04562102681007
    PMA / PMN Number
    K203533NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: ASAHI INTECC (THAILAND) CO., LTD., PATHUM THANI, THAILAND, REGISTRATION NUMBER: 3003780911 THE REPORTED VASSALLO GT FLOPPY .014 GUIDE WIRE ("THE PRODUCT") WAS RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE COIL WIRE WAS STRETCHED WITH THE POLYMER JACKET PEELING OFF AT THE DISTAL SIDE OF THE PRODUCT, AND THE CORE WIRE WAS EXPOSED FOR APPROXIMATELY 163 MM FROM THE DISTAL TIP. IT WAS ALSO CONFIRMED THAT A TEAR HAD OCCURRED AT THE DISTAL TIP OF THE STRETCHED COIL WIRE AND AT THE DISTAL TIP OF THE EXPOSED CORE WIRE, RESPECTIVELY. THROUGH MAGNIFIED OBSERVATION OF THE CRACKED SURFACE OF THE COIL WIRE AND THE CRACKED SURFACE OF THE CORE WIRE USING A SCANNING ELECTRON MICROSCOPE, IT WAS CONFIRMED THAT TWISTING AND DIMPLES WERE GENERATED ON THE CRACKED SURFACE OF THE COIL WIRE DUE TO THE STRETCHING LOAD IN A FORM OF THE COIL SPRING. IN ADDITION, DIMPLES WERE OBSERVED ON THE CRACKED SURFACE OF THE CORE WIRE DUE TO THE STRETCHING LOAD, AND THE CORE WIRE WAS CONFIRMED TO HAVE SHRUNK IN DIAMETER. BASED ON THE RESULTS OF THE EXAMINATION OF THE PRODUCT, THERE WAS A POSSIBILITY THAT A FRAGMENT OF THE CORE WIRE AND COIL WIRE HAD BROKEN OFF AS A RESULT OF THE BREAKAGE. HOWEVER, WE RECEIVED INFORMATION THAT THE FRAGMENTS WERE LIKELY ATTACHED TO THE BALLOON CATHETER THAT WAS USED WITH THE PRODUCT, AND THERE WAS NO RESIDUAL MATERIAL IN THE PATIENT'S BODY. 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 PROVIDED INFORMATION AND INVESTIGATION OUTCOME, IT WAS PRESUMED THAT WHEN THE COMBINED BALLOON CATHETER WAS REMOVED, THE TIP OF THE PRODUCT WAS STUCK IN THE BALLOON CATHETER, WHICH MAY HAVE CAUSED RESISTANCE. SUBSEQUENTLY, THE CORE WIRE OF THE PRODUCT WAS BROKEN AND THE COIL WIRE WAS STRETCHED BY THE LOAD APPLIED TO THE CORE WIRE WHEN THE PRODUCT WAS REMOVED FROM THE BALLOON CATHETER, WHICH EXCEEDED THE STRENGTH OF THE PRODUCT. AS A RESULT OF ABOVE INVESTIGATION, IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTABLE TO PRODUCT QUALITY, BUT GIVEN THE CONDITION OF THE RETURNED PRODUCT, IT WAS UNABLE TO COMPLETELY RULE OUT A POSSIBILITY THAT SOME FRAGMENTS OF THE FRAGMENTS OF COIL WIRE ,CORE WIRE AND POLYMER JACKET MIGHT REMAIN IN THE PATIENT'S BODY. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~DO NOT PUSH THE GUIDE WIRE MORE THAN NECESSARY TO ADVANCE THE TIP THROUGH THE NARROWED PART OF THE VESSEL. (FOR EXAMPLE, DO NOT PUSH THE GUIDE WIRE WHEN THE DISTAL TIP OF THE GUIDE WIRE IS BENT BY THE FORCE OF MANIPULATION.) AFTER CROSSING THE TARGETED AREA,DO NOT ROUGHLY TWIST, PUSH OR PULL THE GUIDE WIRE. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BE DAMAGED OR BREAK APART, WHICH MAY INJURE THE BLOOD VESSEL OR LEAVE FRAGMENTS INSIDE THE VESSEL. [MALFUNCTION AND ADVERSE EFFECTS] ~POSSIBLE COMPLICATIONS AND ADVERSE EVENTS OF GUIDE WIRE USE INCLUDE, BUT ARE NOT LIMITED TO:DAMAGE OF GUIDEWIRE (SEPARATION,BREAKAGE, DAMAGE OF COATING)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VASSALLO GT .014 FLOPPY (THE PRODUCT) WAS USED IN A CASE OF A LESION IN THE BELOW-KNEE AREA WITH MILD CALCIFICATION AND AN OCCLUSION RATE OF 70% TO LESS THAN 100%. AFTER PASSING THROUGH THE LESION (PERONEAL ARTERY STENOSIS) WITH THE PRODUCT, THE PHYSICIAN DILATED THE LESION WITH A BALLOON CATHETER (NANOCROSS ELITE,NON-FILMECC), AND THEN ATTEMPTED TO REMOVE THE BALLOON CATHETER BUT FELT RESISTANCE, SO THE BALLOON CATHETER WAS REMOVED TOGETHER WITH THE PRODUCT. THE PHYSICIAN FOUND THAT COIL PORTION OF THE PRODUCT WAS UNWOUND. THIS PROCEDURE WAS COMPLETED WITHOUT ANY ADDITIONAL INTERVENTION. IT WAS REPORTED THAT THE FRAGMENTS OF THE COIL AND CORE WIRE WERE MOST LIKELY REMOVED BY THE BALLOON CATHETER AND THERE WERE NO REMAINING TORN OR DETACHED FRAGMENTS IN THE PATIENT'S BODY. THERE WERE NO HEALTH HAZARD ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085164 VASSALLO GT PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. NA 200907R011 04562102681007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other