BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE IN DISPENSER

    MDR report key: 16179329 · Received January 16, 2023

    Report

    Report Number
    1649395-2023-00001
    Event Type
    Injury
    Date Received
    January 16, 2023
    Date of Event
    December 14, 2022
    Report Date
    January 16, 2023
    Manufacturer
    GALT MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K021990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE DOES NOT RETURN TO MANUFACTURER FOR EVALUATION YET. RETURN AUTHORIZATION MATERIAL GENERATED FOR THE CUSTOMER IN ORDER TO RETURN SUSPECT DEVICE BACK TO THE MANUFACTURE FOR EVALUATION. INVESTIGATION AT THIS MOMENT PERFORMED ON DEVICE HISTORY AND COMPLAINT HISTORY REVIEW. DEVICE HISTORY RECORD REVIEWED FOR MAIN PRODUCT AND ALL SUBCOMPONENTS, AND IT SHOWS ALL PRODUCTS MANUFACTURED TO SPECIFICATIONS WITHOUT ANY NON-CONFORMITY AND DEVIATION INDICATED. AT THIS MOMENT ROOT CAUSE CANNOT BE DETERMINE UNTIL COMPLAINT SAMPLE RETURN FOR EVALUATION. A FOLLOW UP REPORT WILL SEND TO FDA ONCE COMPLAINT SAMPLE RETURN AND EVALUATION COMPLETED.

    Additional Manufacturer Narrative · 0

    ORIGINAL REPORT SENT TO FDA ON 1/16/2023. ORIGINAL REPORT DOES NOT CONTAIN EVALUATION ON THE DEVICE DUE TO UNAVAILABILITY OF THE DEVICE AT THE TIME OF INITIAL REPORT. COMPLAINT DEVICE SAMPLE THEN RETURNED TO MANUFACTURER FOR EVALUATION ON 1/17/2023. RETURN AUTHORIZATION MATERIAL GENERATED FOR THE CUSTOMER IN ORDER TO RETURN SUSPECT DEVICE BACK TO THE MANUFACTURE FOR EVALUATION. INVESTIGATION AT THIS MOMENT PERFORMED ON DEVICE HISTORY AND COMPLAINT HISTORY REVIEW. DEVICE HISTORY RECORD REVIEWED FOR MAIN PRODUCT AND ALL SUBCOMPONENTS, AND IT SHOWS ALL PRODUCTS MANUFACTURED TO SPECIFICATIONS WITHOUT ANY NON-CONFORMITY AND DEVIATION INDICATED. GALT MANUFACTURED (700) UNITS OF GID-022-11 (S19301575) AND (S20118431); ALL QUANTITY SHIPPED TO MEDLINE. THE CUSTOMER HAD AN ISSUE WITH ONE UNIT, SATURATION LEVEL FOR THIS OCCURRENCE IS 0.14%. THIS NONCONFORMANCE RELATED TO SUBCOMPONENT GWA-022-11. THESE TWO ABOVE LOTS OF GID-022-11 MADE FROM (3) LOTS OF GUIDEWIRES (GWA-022-11) AND THE TOTAL UNITS MANUFACTURED FROM GWA WAS (3031) PCS. GWA-022-11 (S19269694) MANUFACTURED (1010) PCS. GWA-022-11 (S20065447) MANUFACTURED (1016) PCS. GWA-022-11 (S20080404) MANUFACTURED (1005) PCS. GID-022-11 (S19301575) CONTAIN (500) PCS OF GWA-022-11 LOT (S19269694). GID-022-11 (S20118431) CONTAIN (168) PCS OF GWA-022-11 LOT (S20080404) AND (32) PCS OF LOT (S20065447). GALT USED THE REMAINDER UNITS OF GWA-022-11 WITH OTHER WORK ORDERS TO MANUFACTURE VARIOUS PRODUCT, AND THERE WAS NO COMPLAINT RECORD RECEIVED BY GALT RELATED TO GWA-022-11; THEREFORE, OVERALL SATURATION LEVEL FOR THIS OCCURRENCE IS 0.033%. ACCORDING TO THE CUSTOMER THERE WAS AN ADVERSE EVENT OCCURRED. DHR REVIEW: DHRS HAVE BEEN REVIEWED FOR MAIN PRODUCT AND SUBCOMPONENTS; THERE WAS NO ABNORMALITY OR NONCONFORMANCE RECORDED. ALL PARTS WERE MANUFACTURED ACCORDING TO GALT DRAWING SPECIFICATIONS. FMEA REVIEW: FMEA-020 Y HAS BEEN REVIEWED AND ISSUE OCCURRING UNDER EXPECTED RATE ACCORDING TO PRODUCT FMEA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY RECORD HAS BEEN REVIEWED DURING LAST FIVE YEARS AND THERE WERE (124) RECORDS RELATED TO WIRE. (98%) OF RECORDS RELATED TO END USER ERROR OR NO SAMPLES RETURNED BACK AND ONLY (2%) WAS CONFIRMED. INVESTIGATION: INVESTIGATION PER DHRS SHOWS NO ABNORMALITY OR NONCONFORMANCE WAS RECORDED DURING PRODUCT MANUFACTURING AND ASSEMBLY. ONE COMPLAINT SAMPLE OF GID-022-11 RETURNED BACK, AND PHOTOS WERE TAKEN SHOWS IN FAILURE INVESTIGATION REPORT. PHOTO (1) FOR STAINLESS STEEL COIL SPRING WIRE SHOWS THE WIRE UNRAVELED. THIS APPEAR TO BE OFF LABEL USE. PHOTO (2) SHOWS WIRE BROKEN FROM CORE NEAR DISTAL PORTION; POSSIBLE ROOT CAUSE EXCESSIVE OR WRONG TECHNIQUES USED WHILE WIRE WITHDRAW FROM INSIDE PATIENT. PHOTO (3) SHOWS PROXIMAL SOLDERED PORTION FOR THE WIRE AND THERE ARE MANY SCRATCHES, DUE TO WITHDRAWING THE GUIDEWIRES OVER THE NEEDLE. GUIDEWIRE CAN'T BE WITHDRAWN THROUGH METAL NEEDLES; GUIDEWIRE MAY SHEAR OR UNRAVEL. PHOTO 4; SHOWS CORE SINGLE TAPER WIRE MEASURED AT THE POINT OF BREAK AND THE RESULTS IS (0.0045"), THE MEASUREMENT IS WITHIN SPEC PER GALT DRAWING (0.00425" +/- .0004"). ALSO, BALL WELD SEPARATED FROM CORE WIRE. PHOTO 5; CORE WIRE, THE DAMAGE PORTION APPEARS FROM VARIOUS ANGLES; POSSIBLE ROOT CAUSE FOR THIS OVER TORQUE BY END USER THAT LEADS TO BROKE/ SEPARATION OF COIL SPRING AND BALL WELD. GALT FILED MDR REPORT TO FDA UNDER GALT REPORT NUMBER (1649395-2023-00001) ROOT CAUSE: POSSIBLE ROOT CAUSE FOR THIS OCCURRENCE; END USER ERROR. RECOMMENDATIONS A RECOMMENDATION MADE TO THE CUSTOMER/DISTRIBUTER/END USER/USER TO ADHERE TO IFU.

    Description of Event or Problem · 0

    THE CUSTOMER STATING THE GUIDEWIRE UNRAVELED WHILE IN THE PATIENT'S ARM. THE INCIDENT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY TO THE PATIENT THAT REQUIRED MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    THE CUSTOMER STATING THE GUIDEWIRE UNRAVELED WHILE IN THE PATIENT'S ARM. THE INCIDENT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY TO THE PATIENT THAT REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135024 GUIDEWIRE IN DISPENSER GW, 0.018X65CM NT MANDREL SS DQX GALT MEDICAL CORPORATION GID-022-11 S19301575 AND S20118431

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other