BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE LUMEN EMBOLECTOMY CATHETER

    MDR report key: 7426568 · Received April 12, 2018

    Report

    Report Number
    1220948-2018-00014
    Event Type
    Injury
    Date Received
    April 12, 2018
    Date of Event
    March 7, 2018
    Report Date
    May 9, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DXE
    UDI-DI
    00840663100477
    PMA / PMN Number
    K992368
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT WITH REFERENCE TO MANUFACTURER'S REPORT # 1220948-2018-00014 THAT WAS PREVIOUSLY SUBMITTED ON 04/12/2018. DURING OUR INITIAL REPORT, WE COULD NOT VERIFY IF THE DEVICE INVOLVED IN THIS INCIDENT WAS A LEMAITRE EMBOLECTOMY CATHETER SINCE THE PICTURE SENT BY THE HOSPITAL CONTAINED LABEL WITH A DIFFERENT LOT NUMBER AND CATALOG NUMBER IN WHICH THE DEVICE WAS PACKAGED. ON 13/04/2018, WE WERE ABLE TO CONFIRM THAT THE DEVICE WAS INDEED A LEMAITRE EMBOLECTOMY CATHETER BUT WAS PACKAGED IN A BAG WITH DIFFERENT REFERENCE NO. AND LOT NO. LABEL. WE HAVE NOT YET RECEIVED THE DEVICE FOR EVALUATION. HOWEVER, WE HAVE RECEIVED ADDITIONAL PICTURES OF THE DEVICE THAT DISPLAYED THE DEFECTS IN THIS DEVICE. THE LUMEN OF THE CATHETER HAD SEPARATED ABOUT 6 INCHES BELOW FROM THE TIP OF THE CATHETER. THE PROXIMAL LIGATURE HAD SLIPPED FROM ITS INTENDED POSITION AND SEEMS TO HAVE COVERED THE INFLATION HOLE. AS A RESULT, THE SURGEON COULD NOT DEFLATE THE BALLOON. FROM OUR INVESTIGATION FOR SIMILAR COMPLAINTS, WE HAVE FOUND THAT THIS TYPE OF DEFECT OCCURS WHEN THE BALLOON IS PULLED WITH EXCESSIVE FORCE DURING THE PROCEDURE. IT IS POSSIBLE THAT THE TORTUOUS ANATOMY OF THE PATIENT, CALCIFIED PLAQUE IF PRESENT IN THE PATIENT'S VESSEL AND EXCESSIVE TENSION ON THE DEVICE DURING THE PROCEDURE COULD ALSO LEAD TO THIS FAILURE. AS STATED IN IFU, TO MINIMIZE THE RISK OF BALLOON RUPTURE/SEPARATION, MAXIMUM RECOMMENDED INFLATION VOLUME AND PULL FORCE FOR THE CATHETER SHOULD NOT BE EXCEEDED. 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. WE PERFORM 100% INSPECTION ON EACH DEVICE TO ENSURE THAT THE LIGATURE PROPERLY BINDS TO THE SHAFT AND AN ADEQUATE AMOUNT OF GLUE IS PRESENT IN THE LIGATURE. HOWEVER, IT IS ALSO POSSIBLE THAT THE TENSION ON THE LIGATURE OR THE GLUE APPLIED UNDERNEATH THE BALLOON PRIOR TO THE BALLOON TYING PROCESS WAS INADEQUATE IN THIS DEVICE RESULTING IN THE SLIPPAGE OF THE LIGATURE FROM ITS POSITION. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. WE HAVE REQUESTED FOR ADDITIONAL INFORMATION FROM THE HOSPITAL RELATED TO THIS INCIDENT. HOWEVER, WE HAVE NOT RECEIVED ANY RESPONSE BACK FROM THE HOSPITAL. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPENED TO INVESTIGATE POSSIBLE ROOT CAUSES OF THIS ISSUE. THE CORRECTIVE ACTION INCLUDES REVIEW OF OUR MANUFACTURING PROCESSES, MATERIALS AND HANDLING OF THE DEVICE.

    Description of Event or Problem · 0

    THE CATHETER WAS STUCK UPON ENTERING A COLLATERAL VARIANT OF THE SUPERFICIAL FEMORAL ARTERY BECAUSE THE BALLOON DID NOT DEFLATE. IT WAS INITIALLY NOT POSSIBLE TO REMOVE THE BALLOON, EVEN AFTER PUNCTURING IT. IT WAS NECESSARY TO DRY THE COLLATERAL VARIANT TO REMOVE THE CATHETER.

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. HOWEVER, WE HAVE RECEIVED THE PICTURE OF THE DEFECTIVE DEVICE FROM OUR DISTRIBUTOR. THE CATHETER SHOWN IN THE PICTURE WAS NOT MANUFACTURED BY LEMAITRE. AT THIS TIME, WE ARE STILL INVESTIGATING IF A WRONG DEVICE WAS SENT TO THE DISTRIBUTOR BY THE HOSPITAL OR THE WRONG DEVICE WAS REPORTED BY THE HOSPITAL. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE PROVIDED IF WE DETERMINE IT WAS THE LEMAITRE SINGLE LUMEN CATHETER THAT RESULTED IN THIS INCIDENT. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THE REPORTED LOT NUMBER DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF SIMILAR NATURE FOR DEVICES FROM THIS LOT. THE DISTRIBUTOR WHO REPORTED THIS INCIDENT TO US HAD TRIED SEVERAL TIMES TO REACH THE CONTACT PERSON IN THE HOSPITAL BY PHONE AND ALSO WENT THERE TWICE PERSONALLY, BUT WAS UNABLE TO OBTAIN ANY MORE INFORMATION ON THIS INCIDENT. AT THIS TIME, WE ARE UNABLE TO CONFIRM THAT A LEMAITRE DEVICE WAS INVOLVED IN THIS ISSUE. HOWEVER, SHOULD WE CONFIRM THE DEVICE TO BE MANUFACTURED BY LEMAITRE VASCULAR, INC, THEN WE WILL APPLY TRENDING AND ROOT CAUSE ANALYSIS TO DETERMINE IF FURTHER CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CATHETER WAS STUCK UPON ENTERING A COLLATERAL VARIANT OF THE SUPERFICIAL FEMORAL ARTERY BECAUSE THE BALLOON DID NOT DEFLATE. IT WAS INITIALLY NOT POSSIBLE TO REMOVE THE BALLOON, EVEN AFTER PUNCTURING IT. IT WAS NECESSARY TO DRY THE COLLATERAL VARIANT TO REMOVE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267049 SINGLE LUMEN EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE LEMAITRE VASCULAR, INC. SLC4316 00840663100477

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention