BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 7427129 · Received April 12, 2018

    Report

    Report Number
    1820334-2018-00776
    Event Type
    Death
    Date Received
    April 12, 2018
    Date of Event
    March 14, 2018
    Report Date
    March 26, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K142829
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: AGE (B)(6), PATIENT IS A WHITE MALE. INVESTIGATION EVALUATION: A REVIEW OF THE DRAWINGS, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO AID THE INVESTIGATION. NO IMAGES OR VIDEOS OF THE FAILURE WERE PROVIDED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. A COMPLAINT HISTORY SEARCH WAS ALSO UNABLE TO BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. A PATIENT WITH DIABETES MELLITUS, HYPERLIPIDEMIA AND HYPERTENSION IS ALREADY AT RISK FOR CALCIFIED AND NARROWED ANATOMY. THERE WAS RESISTANCE UPON REMOVAL AND THE DILATOR WAS NOT IN THE SHEATH DURING REMOVAL. IFU T_INTRO STATES, ¿SHEATH REMOVAL: INSERT THE INTRODUCER DILATOR OVER THE WIRE INTO THE SHEATH. WITHDRAW THE SHEATH AND DILATOR AS A UNIT.¿ ALSO, ¿DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT.¿ THERE IS NO INFORMATION REGARDING THE DEVICE USED IN THE SHEATH OR OTHER DEVICES AND IF THESE DEVICES MET THEIR MANUFACTURER¿S QUALITY SPECIFICATIONS. PER THE IFU, ¿UPON REMOVAL FROM PACKAGE, ENSURE THE INNER DIAMETER (ID) OF THE INTRODUCER IS APPROPRIATE FOR THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED.¿ ALSO, ¿THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED SHOULD BE DETERMINED TO ENSURE ITS PASSAGE THROUGH THE INTRODUCER. ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT.¿ THERE IS NO EVIDENCE TO SUGGEST ANY CAUSAL RELATIONSHIP BETWEEN THE COMPLAINT DEVICE SEPARATION AND THE PATIENT DEATH. THERE WAS A TWO DAY PERIOD BETWEEN INSERTION OF THE DEVICE AND PATIENT DEATH WITH NO TIMELINE OF EVENTS DURING THAT PERIOD. CONSIDERING ON AVERAGE THE HUMAN BODY CONTAINS APPROXIMATELY 5 LITERS OF BLOOD, A 2.5 LITER LOSS WOULD BE CATASTROPHIC. NONETHELESS, IT IS NOT CLEAR WHY THERE WAS SO MUCH BLOOD LOSS. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME, HOWEVER APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENTS. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    PER THE INITIAL REPORTER, THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS HAVING INFORMATION NOT PREVIOUSLY REPORTED. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) Y/O WOMAN UNDERWENT A LEG RUNOFF AORTO-ILIAC FEMORAL (AIF) PROCEDURE ON (B)(6) 2018 WHEN THE FLEXOR ANSEL GUIDING SHEATH HUB SEPARATED AND THE DEVICE UNRAVELED. ACCESS WAS GAINED VIA CONTRALATERAL APPROACH THROUGH THE PATIENT'S LEG. ACCORDING TO THE INITIAL REPORTER, THERE WASN'T ANY RESISTANCE UPON INSERTION OF THE COMPLAINT DEVICE. ANOTHER MANUFACTURER'S WIRE GUIDE WAS BEING UTILIZED THROUGH THE SHEATH DURING THE EVENT. THERE WAS SOME RESISTANCE NOTED UPON REMOVAL OF THE FLEXOR SHEATH, AND IT WAS NOTED THAT ALTHOUGH THE PREVIOUSLY MENTIONED WIRE GUIDE WAS IN PLACE, THE DILATOR WAS NOT INSIDE THE SHEATH DURING THE ATTEMPTED REMOVAL. THE PATIENT'S ANATOMY WAS ALSO NOTED TO BE CALCIFIED. AS THE SHEATH WAS PULLED OUT OF THE PATIENT'S ANATOMY, THE HUB SEPARATED FROM THE DEVICE AND THE SHEATH BEGAN TO UNRAVELED FURTHER DOWN THE SHAFT. THERE ARE NO PHOTOS OR IMAGING AVAILABLE OF THE EVENT. AS THE SHEATH WAS UNABLE TO BE REMOVED ENDOVASCULARLY, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF THE SHEATH. THE CASE WAS REPORTED TO HAVE TAKEN FIVE HOURS. THE ADDITIONAL PROCEDURES INCLUDE A FEMORAL BYPASS OF THE RIGHT GROIN AND PRIMARY CLOSURE OF THE LEFT GROIN. THE PATIENT EXPIRED ON (B)(6) 2018 DUE TO CARDIAC PULMONARY ARREST. ACCORDING TO THE INITIAL REPORTER, SIGNIFICANT BLOOD LOSS, APPROXIMATELY 2500 ML, OCCURRED IN THE OPERATING ROOM FROM A SOURCE OTHER THAN THE INITIAL PROCEDURE ACCESS SITE. THE PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE (CAD), A CORONARY ARTERY BYPASS GRAFT (CABG), DIABETES MELLITUS (DM), HYPERLIPIDEMIA, HYPERTENSION HTN), PULMONARY VASCULAR DISEASE (PVD), AND CATARACT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270048 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death| R