BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION

    MDR report key: 7693770 · Received July 17, 2018

    Report

    Report Number
    2522007-2018-00017
    Event Type
    Death
    Date Received
    July 17, 2018
    Date of Event
    June 8, 2018
    Report Date
    June 27, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DXE
    PMA / PMN Number
    K961992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE AFFECTED PRODUCT WAS NOT RETURNED FOR A PHYSICAL EXAMINATION AND THEREFORE THE ACTUAL DEVICE WAS NOT EVALUATED. NO PHOTOS OR X-RAYS WERE PROVIDED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE INSTRUCTIONS FOR USE WAS REVIEWED AND LISTED AS A POTENTIAL ADVERSE EVENT IS 'LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM.' OTHER METHODS INCLUDED REVIEW OF COMPLAINT HISTORY AND REVIEW OF TRENDS. THE COMPLAINT COULD ONLY BE CONFIRMED THROUGH CUSTOMER TESTIMONY. THIS COMPLAINT FAILURE WILL BE MONITORED, TRACKED AND TRENDED PER THE POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESS.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DXE. THE EVENT IS CURRENTLY UNDER INVESTIGATION, HOWEVER, THE DEVICE WILL NOT BEEN RETURNED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION, WAS USED IN A LEAD EXTRACTION PROCEDURE. THE REMOVAL WAS INDICATED DUE TO (B)(6) INFECTION WITH NO EVIDENT VEGETATIONS ON TEE IN A (B)(6) WHITE FEMALE. THE PATIENT HAD PRE-EXISTING CONDITIONS SUCH AS THROMBOCYTOPENIA, CLASS B CIRRHOSIS OF THE LIVER DUE TO HEAVY ALCOHOLISM. PATIENT WAS LISTED AS NON-COMPLIANT WITH MEDICAL THERAPIES AND A LONG STANDING SMOKER. UPON INITIAL REFERRAL OF THIS PATIENT, THE PHYSICIAN EXPRESSED HIS CONCERNS FOR THE LEVEL OF RISK ASSOCIATED WITH THE EXTRACTION, BUT MORE SO FOR HER CURRENT MEDICAL STATE THAT THE EXTRACTION ALONE MAY NOT SOLVE HER CONDITION. HE SHARED HIS CONCERNS WITH INSIDE AND OUTSIDE COUNCIL, INCLUDING SPEAKING TO A PROMINENT HIGH VOLUME EXPERIENCED EXTRACTOR. HE WAS TOLD THAT THE LEAD SHOULD BE REMOVED, SO HE PROCEEDED TODAY. THE LEADS WERE A DUAL COIL ICD LEAD (BOSTON SCIENTIFIC 0185) AND A RIGHT ATRIAL LEAD (BOSTON SCIENTIFIC 4054). BOTH LEADS WERE IMPLANTED (B)(6) 2006 INCLUDING THE ICD GENERATOR. THERE WAS DIFFICULTY ENCOUNTERED IN THE INNOMINATE/SVC JUNCTION DUE TO VISIBLY APPARENT CALCIUM TISSUE, WHICH WAS ATTEMPTED BY USING MULTIPLE TOOLS. THE LEADS WERE PREPPED WITH LLD EZ LOCKING STYLETS (SPECTRANETICS). STARTED WITH 0185 ICD LEAD WITH A 14FR GLIDELIGHT AND 33 CM VISISHEATH USING 17 SECONDS LASER TIME AND 1485 PULSES(SPECTRANETICS). MET STALLED PROGRESSION AND SWITCHED TO 4054 RA LEAD AND USED 12 SECONDS LASER TIME AND 1115 PULSES WHICH MET STALLED PROGRESS AT THE SAME INNOMINATE/SVC AREA. A 11FR TR MINI (SPECTRANETICS) WAS THEN USED WITH STALLED PROGRESS ON RV LEAD AND THEN SWITCHED TO RA LEAD WITH STALLED PROGRESS. THEN A 13FR SUB-C TR (SPECTRANETICS) WAS USED WITH STALLED PROGRESS ON THE RV LEAD, BUT WAS SUCCESSFULLY REMOVING THE RA LEAD. A 13FR TIGHTRAIL (SPECTRANETICS) WAS ATTEMPTED TO ATTEMPT TO GET BETTER COAXIAL ALIGNMENT ON THE RV LEAD. THIS ATTEMPT WAS UNSUCCESSFUL, SO A DECISION WAS MADE TO ATTEMPT FEMORAL SNARING TO GAIN A BETTER ANGLE ON THE LEAD. A 20 MM NEEDLES EYE SNARE WAS USED SUCCESSFULLY FROM THE RIGHT GROIN, LEAVING THE BRIDGE BALLOON IN PLACE IN THE LEFT GROIN, IN CASE THERE WAS A SVC TEAR. THE PHYSICIAN SUCCESSFULLY SNARED THE RV LEAD AND PULLED DOWN AND HAD HIS ASSISTANT HOLD TRACTION, WHICH HE REATTEMPTED THE 13FR TIGHTRAIL. THIS WAS UNSUCCESSFUL, SO HE WANTED TO TRY A 16FR GLIDELIGHT (SPECTRANETICS) TO SEE IF THAT WOULD HELP. AFTER 2 SECONDS OF LASER TIME AND 132 PULSES HE DECIDED HE WOULD FULLY COMMIT TO REMOVING THE LEAD FROM BELOW (FEMORALLY). HE PULLED ON THE LEAD FROM BELOW (FEMORALLY) AND THE RV LEAD TIP CAME FREE FIRST. HE WAS ABLE TO ENTRAP THE DISTAL TIP OF THE RV LEAD INTO THE FEMORAL SHEATH AND WORK THE SHEATH UP INTO THE SVC TO GIVE SUPPORTIVE TRACTION, WHICH SUCCESSFULLY REMOVED THE LEAD IN IT¿S ENTIRETY. REVIEW OF THE TEE SHOWED A PERICARDIAL EFFUSION THAT WAS SMALL AND THE HEMODYNAMICS WERE STABLE WITH A BP OF 105/78. THIS WAS WATCHED CLOSELY AND WITHIN 2 MINUTES THE BP WAS IN THE HIGH 60¿S TO 70¿S SYSTOLIC. THE BRIDGE BALLOON WAS UP PROPHYLACTICALLY AND INFLATED PRIOR TO MAKING THE DECISION TO PERFORM A STERNOTOMY. AN IMMEDIATE STERNOTOMY WAS PERFORMED AND TAMPONADE WAS RELEASED. I THOUGHT FOR SURE THIS HAD TO BE A SVC TEAR AND THAT THE BALLOON HAD SAVED THE DAY. THE BP WAS 115 SYSTOLIC. ONCE OPEN THERE WAS NO EVIDENT TEAR IN THE SVC OR INNOMINATE, WHICH WAS SURPRISING DUE TO THE AMOUNT OF CALCIFIED SCARRING THAT WAS SEEN ON THE LEAD AFTER IT WAS SNARED FREE. MEANING THE LOCATION OF THE SEVERE SCARRING AND TISSUE WAS AT THE INNOMINATE/SVC, NOT AT THE RV LEAD TIP. THERE WAS EVIDENT BLEEDING FROM THE RV APEX, WHICH COULDN¿T BE REPAIRED WITHOUT DECOMPRESSING THE HEART BY GOING ON BYPASS MACHINE. THE PHYSICIAN DESCRIBED THE INJURY AS A 2 TO 3 MM PERFORATION THAT WAS CAUSED BY THE TRACTION ON THE LEAD BY SNARING IT FREE AND NOT BY THE USE OF ANY OF OUR EXTRACTION TOOLS. SNARING WAS SUCCESSFUL, BUT IT ULTIMATELY RESULTED IN A RV TEAR, WHICH WAS REPAIRED USING A PLEDGET TO SEAL THE SMALL HOLE WHILE ON BYPASS PUMP CIRCULATION. A TOTAL OF 5-6 UNITS OF PLATELETS AND RBC¿S (MOSTLY PLATELETS) WERE GIVEN ALONG WITH CELL SAVER SUPPORT DURING THE RESCUE DUE TO THE PREOPERATIVE CONDITION OF THROMBOCYTOPENIA. THE PATIENT SURVIVED THE RESCUE AND WAS EXTUBATED THE FOLLOWING DAY, HOWEVER HER CONDITION WAS CRITICAL DUE TO HER OVERALL HEALTH PRIOR TO THE EXTRACTION AND THE INFECTION HER BODY WAS FIGHTING OFF. SHE EXPIRED ON (B)(6) 2018. INJURY LOCATION: RV APEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538637 LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION EMBOLECTOMY CATHETER DXE COOK VASCULAR INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death SPECTRANETIC DEVICES (6) TOTAL