BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-INTRODUCER KIT

    MDR report key: 14593981 · Received June 3, 2022

    Report

    Report Number
    1649395-2021-00007
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    July 6, 2021
    Report Date
    July 26, 2021
    Manufacturer
    GALT MEDICAL CORPORATION
    Product Code
    OGF
    UDI-DI
    10841268104737
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GALT MANUFACTURED (200) UNITS OF KIT-002-28 (G20020165) AND SHIPPED (110) TO THE VASOCARE. THE CUSTOMER HAD AN ISSUE WITH ONE SUBCOMPONENTS OF GWA-055-41, SATURATION LEVEL FOR THIS 0.09%. ACCORDING TO END USER, THE GUIDEWIRES BROKE OFF AND REMAINED IN THE PATIENT'S BODY BUT THEN IT WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS FINISHED. DHRS HAVE BEEN REVIEWED FOR MAIN PRODUCT AND SUBCOMPONENTS; THERE WERE NO ABNORMALITY OR NONCONFORMANCE FOUND. ALL PARTS WERE MANUFACTURED ACCORDING TO GALT. FMEA-020U HAS BEEN REVIEWED. ISSUE OCCURRING UNDER EXPECTED RATE ACCORDING TO PRODUCT FMEA. COMPLAINT HISTORY RECORD HAS BEEN REVIEWED DURING LAST FIVE YEARS AND THERE WERE (97) RECORDS RELATED TO WIRE. (89%) OF RECORDS RELATED TO END USER ERROR OR NO SAMPLES RETURNED BACK. (8%) RECORDS ARE FOR UNRELATED FAILURE CATEGORIES AND ONLY (3%) WAS CONFIRMED. REGARDING THE CUSTOMER NON-CONFORMANCE; ONE SAMPLE OF GWA-055-41 RETURNED BACK AND QUALITY TEAM TOOK SOME PHOTOS FOR EVALUATION AND ALL PHOTOS WERE ATTACHED TO FAILURE INVESTIGATION REPORT. RETURNED WIRE FROM THE CUSTOMER SHOWS IT WAS BENT FROM MANDREL PORTION TO 90 DEGREE ANGLE, THIS MIGHT HAPPENED WHILE ATTEMPTING TO WITHDRAW WIRE FROM PATIENT BODY BY END USER. PHOTOS FOR RETURNED SAMPLES SHOWS CORE WIRE SEPARATION FROM DISTAL TIP AND BROKE OFF IN THE PATIENT BODY BEFORE RETRIEVED. THE RETURNED WIRE MEASURED AND IT WAS FOUND APPROXIMATELY (38.5 CM). GUIDEWIRE LENGTH SPEC PER GALT ENG DWG IS (39.5 - 40.5 CM.), SO APPROXIMATE LENGTH OF BROKEN PORTION IS (1-1.5CM). THIS PORTION DID NOT RETURN TO GALT. ALSO, INVESTIGATION AND EVALUATION ON RETURNED SAMPLES SHOWS BROKEN PORTION OF THE WIRES THAT REMAINED IN PATIENT BODY AND REMOVED LATER, BUT THIS PORTION DID NOT RETURN TO GALT AND IT WAS DISCARDED BY END USER. SAMPLES SHOWS SOLDERED AREA DIDN'T FRACTURE AFTER RETRIEVED FROM PATIENT BODY THIS SHOWS THAT THE GUIDEWIRES WAS MANUFACTURED TO SPECIFICATION WITHOUT ANY ABNORMALITY INDICTED.MANUFACTURING DOCUMENTATIONS INDICATES THAT PURCHASED MATERIALS (PASS) GALT INCOMING INSPECTIONS REQUIREMENTS, AND THE DHRS, DRAWING CONFIRMED ALL PARTS WERE MANUFACTURED TO SPECIFICATIONS WITHOUT ANY ABNORMALITY OR DEVIATIONS INDICATED. THE INFORMATION BELOW WAS ACQUIRED FROM RANDOM SELECTED (10) SAMPLES FOR FINISHED GOODS OF GWA-055-41 FOUND IN GALT INVENTORY: TENSILE PULL FORCE FOR BALL WELD JOINT AT DISTAL TIP IS HIGHER THAN MINIMUM REQUIRED PER ENGINEERING DRAWINGS AND ISO: (B)(4)(GALT PULL TEST MIN. (B)(6) LBS.) AND AVERAGE RESULTS WAS ((B)(6) LBS.).AVERAGE TENSILE PULL FORCE @ 1CM FROM UNCOILED DISTAL TIP CORE WIRE WITHOUT BALL WELD JOINT WAS (B)(6) LBS.1-SAMPLE (1) (B)(6) LBS.2-SAMPLE (2) (B)(6) LBS. AVERAGE TENSILE PULL FORCE @ 3CM FROM UNCOILED DISTAL TIP CORE WIRE WITHOUT BALL WELD JOINT WAS (B)(6)LBS.1-SAMPLE (1) (B)(6) LBS.2-SAMPLE (2) (B)(6) LBS. GALT QUALITY TEAM RECREATE THIS DEFECT TO COMPARE WITH COMPLAINT SAMPLE BY INSERTING COAXIAL DILATOR INTO SYNTHETIC SKIN PAD THEN THE GUIDEWIRE WAS INSERTED INSIDE THE SHEATH AND EXTRACTED (10) TIMES, RESULTS SHOWS THERE WAS NO INDICATION OF ANY DAMAGE TO THE DISTAL TIP OF THE GUIDEWIRE.THIS INVESTIGATION PROVIDE EVIDENCE THAT GWA-055-41 SS/ GALT GOLD MANUFACTURED TO THE SPECIFICATION AND GALT DOES NOT HAVE ANY HISTORY OF NON-CONFORMANCES RELATED TO THE PROCESS OR DESIGN OF CRW-014-08 WHICH IS USED IN THE FINISHED STERILE GWA-055-41. ACCORDING TO THE COMPLAINT DESCRIPTION "DR. CHAEWAN I AM USED A 22G NEEDLE WHICH IS NOT FROM GALT," SO BASICALLY 22G NEEDLE INNER DIAMETER IS TIGHTER THAN 21G NEEDLE THAT GALT PROVIDED WITH KIT-002-28. EVALUATION FOR THIS OCCURRENCE POSSIBLE GUIDEWIRE WAS OBSTRUCTED WITH NEEDLE 22G WHICH IS TIGHTER INNER DIAMETER (NOT GALT NEEDLE) AND WIRE SUBMITTED TO OVER TORQUE THAT CAUSED BROKE OFF DISTAL TIP OF COILED PART ALONG WITH THE CORE PORTION. POSSIBLE ROOT CAUSE FOR THIS OCCURRENCE; END USER DID NOT FOLLOW IFU. RECOMMENDATIONS TO END USER WAS (ADHERE TO IFU)

    Description of Event or Problem · 0

    AS RECEIVED FROM DISTRIBUTOR/END USER "THE PATIENT WHO TRIED TO TAKE AN ANGIOGRAPHY WITH USING 4FR MIK EXCEPT THE NEEDLE. DR. (B)(6), I AM USED A 22G NEEDLE WHICH IS NOT FROM GALT, AND ONLY USED GUIDE WIRE AND SHEATH WHICH ARE FROM GALT. FIRSTLY HE PUNCTURED WITH 22G NEEDLE, PUT IN THE GUIDE WIRE, TOOK OUT THE NEEDLE, AND PUT IN THE SHEATH. AFTER THAT, HE TRIED TO PULL OUT THE GUIDE WIRE, BUT HE FELT IT WAS STUCK IN SOMEWHERE. HE TRIED TO PULL OUT THE GUIDE WIRE GENTLY, BUT IT EVENTUALLY BROKE OFF AND REMAINED IN THE PATIENT'S BODY. EVENTUALLY, THE PATIENT DIDN'T GET ANGIOGRAPHY AND THE GUIDE WIRE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS FINISHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557011 MICRO-INTRODUCER KIT KIT-002-28, 4F MICRO-INTRODUCER KIT, PACKAGED STERILE OGF GALT MEDICAL CORPORATION KIT-002-28 G20020165 10841268104737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other