BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER

    MDR report key: 5434958 · Received February 12, 2016

    Report

    Report Number
    1220948-2016-00004
    Event Type
    Injury
    Date Received
    February 12, 2016
    Date of Event
    January 18, 2016
    Report Date
    January 27, 2016
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DXE
    UDI-DI
    00840663100606
    PMA / PMN Number
    K992368
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND WERE ABLE TO CONFIRM THE FAILURE. THE BALLOON WAS DETACHED. ADDITIONALLY, WE FOUND THAT THE LUMEN WAS ELONGATED AND DAMAGED, AND THIS PREVENTED FLOW THROUGH THE LUMEN. A LOT HISTORY INVESTIGATION WAS PERFORMED. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESSES AND THERE WERE NO UNRESOLVED ISSUES RELATED TO THE COMPLAINT EVENT. THEREFORE, WE CONCLUDED THAT MOST LIKELY THE DEVICE WAS CAUGHT ON THE STENT DURING THE PROCEDURE AND WAS DAMAGED DURING THE ATTEMPTS TO REMOVE THE CATHETER FROM THE PATIENT. AS IS COMMON WITH OTHER CATHETERIZATION PROCEDURES, COMPLICATIONS MAY OCCUR DURING USE OF EMBOLECTOMY CATHETERS. THESE MAY INCLUDE INTIMAL DISRUPTION, VESSEL WALL PERFORATION, BALLOON RUPTURE WITH FRAGMENTATION, TIP SEPARATION, LOCAL OR SYSTEMIC INFECTION, ARTERIAL THROMBOSIS, LOCAL HEMATOMAS, AIR EMBOLUS, RUPTURE OF ANEURYSM, ARTERIAL SPASM, DISTAL EMBOLUS OF BLOOD CLOTS OR ARTERIOSCLEROTIC PLAQUE, ARTERIAL DISSECTION, AND HEMORRHAGE. ALL OF THESE POTENTIAL ADVERSE EVENTS ARE LISTED IN THE LEMAITRE VASCULAR, INC. IFU. NOTE: THE HOSPITAL COULD NOT CONFIRM WHICH EXACT CATHETER LOT (LOT SLC3692 OR SLC3624) WAS INVOLVED IN THE INCIDENT. AS SUCH, BOTH LOT HISTORY RECORDS WERE REVIEWED FOR THIS REPORT AND FOUND TO HAVE NO ISSUES THAT COULD BE RELATED TO THE INCIDENT.

    Description of Event or Problem · 1

    THE BALLOON TIP OF THE LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER BROKE OFF DURING THE PROCEDURE IN THE PATIENT'S COMMON ILLIAC ARTERY. THE CATHETER WAS PASSED SEVERAL TIMES TO REMOVE SOME THROMBUS AND ALLOW BLOOD FLOW. AN ANGIOGRAM INDICATED SOME STENOSIS AND AN ANGIOPLASTY WITH STENT PLACEMENT WAS PERFORMED, BUT BLOOD FLOW WAS STILL DIMINISHED. THE CATHETER WAS AGAIN PASSED WITHOUT DIFFICULTY REMOVING A CHUNK OF THROMBUS AND IMPROVING BLOOD FLOW WHICH REMAINED NON-PULSATILE. THE CATHETER WAS PASSED ANOTHER TIME, BUT THE PHYSICIAN WAS UNABLE TO GET THE CATHETER BACK PAST THE STENT. THE CATHETER LUMEN SNAPPED AND THE REMAINDER OF THE CATHETER CAME OUT. THE AREA WAS VISUALIZED UNDER FLUOROSCOPY AND THE BALLOON WAS NOTED TO STILL BE INFLATED. ATTEMPTS TO DEFLATE THE BALLOON WERE UNSUCCESSFUL AND FINALLY ANOTHER EMOBOLECTOMY CATHETER WAS USED IN AN ATTEMPT TO REMOVE THE BALLOON. THE BALLOON REMAINED STUCK AND IT WAS DEEMED SAFER TO LEAVE THE BROKEN TIP IN THE VESSEL. THE VESSEL WAS TIED OFF AND FEM-FEM BYPASS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92603 LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER SINGLE LUMEN EMBOLECTOMY CATHETER DXE LEMAITRE VASCULAR, INC. E1601-48 SLC3692 00840663100606

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R