BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2780879 · Received October 10, 2012

    Report

    Report Number
    3004939290-2012-00342
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER AND EXPIRATION DATE ARE BEING CORRECTED. INITIAL REPORTED NAME IS BEING CORRECTED. DEVICE MANUFACTURE DATE IS BEING INCLUDED. INVESTIGATION RESULTS IS BEING CORRECTED: THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE REVIEW OF THE LHR (LOT F1212404) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, PRODUCT RELEASE AT ACI IS CONTINGENT UPON THE SUCCESSFUL COMPLETION OF LOT RELEASE TESTING AND A DOCUMENTATION REVIEW BY THE QUALITY DEPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI CLINICAL SPECIALIST THAT A PATIENT UNDERWENT A CATHETERIZATION PROCEDURE ON AN UNKNOWN DATE. THE ACI CLINICAL SPECIALIST REPORTED THE FOLLOWING: "I RECEIVED A PHONE CALL FROM THE SURGICAL COORDINATOR WHO REPORTED THAT THERE WAS A COMPLICATION WITH A PATIENT WHERE THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F WAS USED. I DON'T HAVE MANY DETAILS BUT THE SURGICAL COORDINATOR REPORTED THAT THE PATIENT SUFFERED SERIOUS COMPLICATIONS INCLUDING INTERNAL BLEEDING AND A STROKE. THE SURGICAL COORDINATOR COULD NOT ACCURATELY TELL ME WHEN THE PROCEDURE WAS OR EVEN WHAT TYPE OF PROCEDURE IT WAS." NO FURTHER INFORMATION IS AVAILABLE. ON (B)(6) 2012, ACI RECEIVED A COPY OF A MAUDE EVENT REPORT (VOLUNTARY REPORT # (B)(4)), WHICH WAS SENT TO THE FDA BY THE USER FACILITY. THE REPORT STATED THAT THE DATE OF EVENT WAS (B)(6) 2012 AND THE DATE OF THE REPORT WAS (B)(6) 2012. THE FOLLOWING IS THE DESCRIPTION OF THE COMPLAINT: "THE PATIENT UNDERWENT AN ELECTIVE REPAIR OF AN UNRUPTURED MIDDLE CEREBRAL ARTERY ANEURYSM VIA ENDOVASCULAR COIL TECHNIQUE. A 6 FRENCH RIGHT FEMORAL ARTERY SHEATH WAS USED FOR GROIN ACCESS. AS PER STANDARD TECHNIQUE, THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY. THE PATIENT WAS HEPARINIZED FOR THE PROCEDURE. A MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F WAS DEPLOYED PER THE MANUFACTURER'S RECOMMENDED TECHNIQUE TO SEAL THE ARTERIOTOMY. NO SITE BLEEDING WAS APPARENT AND THE CASE WAS COMPLETED. THE PATIENT WAS EXTUBATED AND FOLLOWING COMMANDS AT MOVING ALL FOUR EXTREMITIES WELL. THE PATIENT BECAME MASSIVELY HYPOTENSIVE AND UNRESPONSIVE SECONDARY TO LOW BLOOD PRESSURE. IMMEDIATE FLUID RESUSCITATION, PRESSORS AND BLOOD PRODUCTS WERE GIVEN TO TREAT SYSTOLIC BLOOD PRESSURE AS LOW AS 30S PER RADIAL ARTERIAL LINE. THE PATIENT'S HCT,AS 10 AT THIS TIME. ONCE THE PATIENT WAS STABILIZED, A CT SCAN OF THE PELVIS WAS DONE WHICH SHOWED "MASSIVE HEMATOMA" ORIGINATING FROM THE RIGHT FEMORAL ARTERY PUNCTURE SITE. AN EMERGENCY ANGIOGRAPHY SHOWED NO EVIDENCE OF ONGOING EXTRAVASATION. HENCE, THE MYNX CLOSURE DEVICE FAILED, LEADING TO EXSANGUINATION OF THE PATIENT AND NEAR-DEATH. THE FOLLOWING DAY A CT SCAN OF THE PATIENT'S HEAD SHOWED EVIDENCE OF INFARCTION WITHIN THE RIGHT MIDDLE CEREBRAL ARTERY DISTRIBUTION. UPON EXTUBATION ON POST-OP DAY #3 THE PATIENT HAS PROFUNDA LEFT HEMIPARESIS. THE PATIENT IS AWAITING TRANSFER TO REHABILITATION." THE PHYSICIAN IS NOT A TRAINED USER. THE ACI SALES PROFESSIONAL WAS CONTACTED BY COMPLAINT HANDLING AND REQUESTED TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1212404

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R