BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION

    MDR report key: 6117962 · Received November 21, 2016

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    Report

    Report Number
    2522007-2016-00010
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 28, 2016
    Report Date
    September 5, 2017
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DXE
    PMA / PMN Number
    K961992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE LEAD EXTRACTION NEEDLE'S EYE SNARE WAS NOT RETURNED FOR A PHYSICAL INVESTIGATION. THE ROOT CAUSE OF THE REPORTED TEAR IN THE RIGHT ATRIUM WHILE REMOVING THE LEAD WAS NOT ABLE TO BE DETERMINED. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED. THIS IS A KNOWN FAILURE MODE FOR THIS DEVICE. THIS FAILURE MODE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU). IT IS LISTED AS A POTENTIAL ADVERSE EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT; NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A RIGHT SIDED LEAD EXTRACTION WAS BEING PERFORMED ON 2 LEADS OF ANOTHER MANUFACTURER'S DEVICE THAT HAD BEEN PLACED FOR 21 YEARS. THE LEAD EXTRACTION LIBERATOR WAS USED TO LOCK BOTH LEADS WITH A ONE TIE ON BOTH LEADS. THE PROCEDURE STARTED WITH A 14FR SLS 2 LASER SHEATHS ON THE RV LEAD THEN SWITCHED TO THE RA LEAD THEN TO A 11FR TIGHT RAIL DEVICE. STARTED ON THE RV LEAD AND STOPPED ADVANCING. WENT TO THE RV LEAD AND AT THAT TIME THE LIBERATOR LOCKING STYLET BROKE. A BULL DOG WAS USED, WENT TO A 16FR LASER SHEATH AND WAS ABLE TO REMOVE THE RV LEAD. WENT TO THE RA LEAD AND COULD NOT ADVANCE, WENT TO A 13FR TIGHT RAIL DEVICE. THE LEAD ON THE BULL DOG BROKE AT THAT TIME. ANOTHER BULL DOG WAS USED AND SWITCHED BACK TO THE 16FR SHEATH WITH A VSI SHEATH. NO ADVANCEMENT. THEN TOOK A COOK BIRD WORKSTATION WITH THE DEFLECTING TIP GUIDE AND A GOOSENECK SNARE AND WAS UNABLE TO GRAB THE LEAD. A 13MM NEEDLE EYE SNARE WAS THEN USED TO SNARE THE LEAD AND PUSHING WITH VISI AND PULLING FROM BELOW CAUSED A 1.5 CM TEAR IN THE RIGHT ATRIUM. OPEN REPAIR WAS DONE TO REPAIR THE TORN ATRIUM. THE PATIENT STABILIZED AND THE LEAD WAS SUCCESSFULLY REMOVED .AT THE TIME OF THIS CALL REPORTING THE EVENT, THE PATIENT WAS STABLE, NEVER CODED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768318 LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION DXE CATHETER, EMBOLECTOMY DXE COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 DA Required Intervention