BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO LEMAITRE VALVULOTOME

    MDR report key: 7940482 · Received October 5, 2018

    Report

    Report Number
    1220948-2018-00077
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 6, 2018
    Report Date
    December 7, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00840663106653
    PMA / PMN Number
    K140042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND WE HAVE CONFIRMED THE REPORTED DEFECT IN THIS DEVICE. WE FOUND THAT ONE OF THE BLADES DID NOT CLOSE INTO THE RETAINER WHEN THE GREEN HANDLE WAS PULLED. THE GAP DISTANCE AND THE SHEATH LENGTH WAS FOUND TO BE WITHIN SPECIFICATION. WE ALSO NOTED THAT THE BLADE WAS SLIGHTLY BENT WHICH COULD HAVE LED TO THIS ISSUE. OUR LOT HISTORY RECORDS REVIEW FOR LOT NUMBER ELVH1378V DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT EITHER IN THE MANUFACTURING OR PACKAGING PROCESSES. PLEASE NOTE THAT WE DO CONDUCT 100% INSPECTION OF THE BLADE ASSEMBLY DURING THE MANUFACTURING PROCESS. OUR QUALITY GROUP ALSO SAMPLES THESE DEVICES BEFORE FINAL PACKAGING TO ENSURE PROPER BLADE ADJUSTMENT. HOWEVER, IT IS POSSIBLE THAT ONE OF THE BLADES WAS NOT WELL ALIGNED DURING THE MANUFACTURING PROCESS. THE BLADE ALIGNMENT PROCESS INCLUDES MANUAL ADJUSTMENT OF EACH BLADE BY THE OPERATOR. OPERATOR ERRORS, THOUGH RARE, ARE POSSIBLE DUE TO THE MANUAL NATURE OF THE ADJUSTMENTS. IT IS ALSO POSSIBLE THAT THE BLADE WAS DAMAGED DURING PACKAGING OR DURING SHIPPING THE DEVICE TO THE HOSPITAL. OUR IFU CLEARLY INFORMS USERS TO INSPECT THE BLADES FOR DAMAGE AND ALIGNMENT PRIOR TO USE. IN THIS CASE, THE USER PROPERLY FOLLOWED THE RISK MITIGATION MEASURES (IFU) AND PROPERLY IDENTIFIED THE ISSUE. WE HAVE PREVIOUSLY IMPLEMENTED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO RESOLVE THIS TYPE OF ISSUE. IN THE CAPA WE MADE A SERIES OF IMPROVEMENTS AND REPLACEMENTS TO OUR MANUFACTURING FIXTURES TO RESOLVE THIS ISSUE. THE CORRECTIVE ACTIONS WE HAVE IMPLEMENTED HAVE ADEQUATELY REDUCED THE RATE OF OCCURRENCE. DEVICE WAS NOT USED IN THE PATIENT. ANOTHER VALVULOTOME WAS USED FOR THE SURGERY.

    Description of Event or Problem · 0

    THE CUTTING BLADES OF THE VALVULOTOME DID NOT OPEN OR CLOSE PROPERLY. THE MALFUNCTION WAS DETECTED DURING PRE-USE CHECK. SO, THE DEFECTIVE DEVICE WAS REPLACED WITH A NEW VALVULOTOME. THIS IS A FOLLOW-UP REPORT OF THE MANUFACTURER'S INCIDENT REPORT THAT WAS INITIALLY SUBMITTED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    WE HAVE NOT YET RECEIVED THE DEVICE FOR EVALUATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER WE EVALUATE THE DEVICE. WE HAVE CONDUCTED A LOT HISTORY REVIEW AND DID NOT FIND ANY ISSUES NOTED IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS ISSUE. ALL QC TESTS PASSED THEIR REQUIREMENTS. ALL OF THE 98 UNITS FROM THIS LOT RELEASED FOR SALE HAVE BEEN SOLD. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT. DEVICE WAS NOT USED IN THE PATIENT. ANOTHER VALVULOTOME WAS USED FOR THE SURGERY.

    Description of Event or Problem · 1

    THE CUTTING BLADES OF THE VALVULOTOME DID NOT OPEN OR CLOSE PROPERLY. THE MALFUNCTION WAS DETECTED DURING PRE-USE CHECK. SO, THE DEFECTIVE DEVICE WAS REPLACED WITH A NEW VALVULOTOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778219 HYDRO LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. ELVH1378V 00840663106653

    Patients

    Seq Age Sex Outcome Treatment
    0