BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 6312293 · Received February 8, 2017

    Report

    Report Number
    2522007-2017-00006
    Event Type
    Death
    Date Received
    February 8, 2017
    Date of Event
    December 23, 2016
    Report Date
    December 15, 2017
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA# K141148. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. CORRECTED INFORMATION: REPORT SOURCE: FOREIGN, HEALTH PROFESSIONAL, USER FACILITY, OTHER (MARKET EVALUATION). INVESTIGATION SUMMARY: A REVIEW OF THE COMPLAINT HISTORY AND INSTRUCTION FOR USE(IFU) WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION WAS PERFORMED. THERE WAS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. NO LOT NUMBER WAS PROVIDED THUS A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED FOR NON-CONFORMANCES OR OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THERE WAS NO EVIDENCE TO SUGGEST ALL ITEMS IN THE LOT OR SIMILAR DEVICES IN HOUSE ARE NONCONFORMING/DEFECTIVE. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE QUALITY ENGINEERING RISK ASSESSMENT FOR THIS FAILURE MODE WAS REVIEWED AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. THE APPROPRIATE PERSONNEL WILL BE NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR TRENDS. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. CORRECTED INFORMATION: REPORT SOURCE: FOREIGN, HEALTH PROFESSIONAL, USER FACILITY, OTHER (MARKET EVALUATION). INVESTIGATION SUMMARY: A REVIEW OF THE COMPLAINT HISTORY AND INSTRUCTION FOR USE(IFU) WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, DEVICE FAILURE ANALYSIS AND PHYSICAL EXAMINATION OF THE DEVICE USED IN THIS CASE COULD NOT BE PERFORMED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION WAS PERFORMED. THERE WAS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. NO LOT NUMBER WAS PROVIDED THUS A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED FOR NON-CONFORMANCES OR OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THERE WAS NO EVIDENCE TO SUGGEST ALL ITEMS IN THE LOT OR SIMILAR DEVICES IN HOUSE ARE NONCONFORMING/DEFECTIVE. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE QUALITY ENGINEERING RISK ASSESSMENT FOR THIS FAILURE MODE WAS REVIEWED AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. THE APPROPRIATE PERSONNEL WILL BE NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT AN (B)(6) MALE PATIENT WITH SEPSIS AND ENDOCARDITIS UNDERWENT A LEAD EXTRACTION PROCEDURE INITIALLY USING A LASER. THE LEAD WAS AN 18 YEAR OLD VENTRICULAR PASSIVE LEAD. HOWEVER, THE PHYSICIAN SWITCHED TO A LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, DUE TO HEAVY CALCIFICATION. ALSO IN USE, A LIBERATOR LOCKING STYLET WITH A ONE-TIE. THE LIBERATOR HAD RETRACTED SLIGHTLY BUT THE EVOLUTION RL PROGRESSED DOWN THE LEAD TOWARDS THE TIP, UPON FREEING THE ACTUAL TIP A TEAR WAS CAUSED AT THE RIGHT VENTRICULAR APEX. THE SURGEONS PREFORMED AN ¿EMERGENCY STERNOTOMY. THE PATIENT DIED. THE DOCTOR STATED, ¿THE EQUIPMENT PERFORMED AS EXPECTED. IT WAS AN UNEXPECTED COMPLICATION IN A HIGH RISK PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WOULD BE A CORONER¿S INQUEST. THERE WAS NOT ANY SECTION OF THE DEVICE REMAINING INSIDE OF THE PATIENT¿S BODY. THE PACKAGE INSERT LISTS ¿LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM¿ AS ONE OF THE POTENTIAL ADVERSE EVENTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93679 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death LEAD EXTRACTION LIBERATOR BEACON TIP STYLET