BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYNXGRIP 6F/7F VASCULAR CLOSURE DEVICE

    MDR report key: 6179737 · Received December 15, 2016

    Report

    Report Number
    3004939290-2016-00347
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE(S) IS BEING CORRECTED: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO (B)(4) FOR EVALUATION. ACCESS SITE HEMATOMAS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE, ADEQUATE SHEATH REMOVAL TECHNIQUE AND PATIENT'S COMPLIANCE TO DECREASE MOBILITY OF LIMB AFFECTED IN ORDER TO PROMOTE COAGULATION. PATIENT AND/OR PHARMACOLOGICAL FACTORS ARE LIKELY CONTRIBUTING FACTORS TO THE HEMATOMA REPORTED. ACCORDING TO THE PRODUCT INSTRUCTION FOR USE, PROLONGED ACCESS SITE-RELATED BLEEDING IS A POTENTIAL RISK ASSOCIATED WITH FEMORAL ARTERY CLOSURE PROCEDURES. FURTHERMORE, USERS ARE INSTRUCTED TO APPLY FINGERTIP COMPRESSION FOR UP TO 1 MINUTE OR AS NEEDED. IF HEMOSTASIS IS NOT ACHIEVED, APPLY ADDITIONAL COMPRESSION AS NECESSARY. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. THE REVIEW OF THE LOT HISTORY RECORD (F1620905) INDICATED THAT THE MYNX DEVICE LOT MET ALL PRODUCT SPECIFICATIONS, INCLUDING QUALITY CONTROL ACCEPTANCE CRITERIA AND STERILIZATION PRIOR TO SHIPMENT. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS USED IN CONJUNCTION WITH AN 8F PROCEDURAL SHEATH. IT SHOULD BE NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU) ALL MYNX PRODUCT FAMILY OF DEVICES WERE INDICATED FOR FEMORAL ARTERIAL CLOSURE UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH (NOT 8F), AS THE SEALANT WILL NOT BE OF SUFFICIENT SIZE TO SEAL THE ARTERIOTOMY THUS ALLOWING BLOOD TO FLOW AROUND THE SEALANT AND POSSIBLY EXPELLING THE SEALANT. IN ADDITION, IT WAS REPORTED THAT THERE WERE TWO HIGH STICK PLACEMENTS PRIOR TO CLOSURE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) WARNINGS SECTION INDICATES THE FOLLOWING: "DO NOT USE THE MYNXGRIP VASCULAR CLOSURE DEVICE IF THE PUNCTURE IS THROUGH THE POSTERIOR WALL OR IF THERE ARE MULTIPLE PUNCTURES, AS SUCH PUNCTURES MAY RESULT IN A RETROPERITONEAL HEMATOMA/BLEED." NO CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED FOLLOWING FEMORAL ARTERIAL CLOSURE WITH THE MYNXGRIP 6F/7F DEVICE. TWO STICK ATTEMPTS WERE MADE BEFORE INTRAVASCULAR ACCESS WAS ACHIEVED. THE PUNCTURE SITE WAS LOCATED BELOW THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA), HOWEVER, IT WAS NOTED TO BE A HIGH STICK. MULTIPLE SHEATH EXCHANGES WERE NOT REQUIRED DURING THE PROCEDURE. THE MYNX DEVICE WAS BEING USED IN CONJUNCTION WITH AN 8F PROCEDURAL SHEATH FOLLOWING AN INTERVENTIONAL PERIPHERAL POST INTRACRANIAL STENT PROCEDURE. HEMOSTASIS WAS ACHIEVED. 10 TO 15 MINUTES LATER, THE PATIENT'S BLOOD PRESSURE DROPPED AND IV VASOPRESSORS WERE GIVEN FOR HYPOTENSION. CODE BLUE WAS CALLED AND CPR WAS INITIATED. DURING CHEST COMPRESSIONS, IT WAS NOTICED THAT THE DEVICE HAD FAILED AND THE PATIENT HAD DEVELOPED A HEMATOMA (UNKNOWN SIZE), SO MANUAL COMPRESSION WAS HELD FOR AN UNKNOWN DURATION. THE PATIENT WAS THEN TRANSFERRED TO THE ICU AND DIED LATER THAT NIGHT. THE CAUSE OF DEATH WAS UNCERTAIN, BUT POSSIBLY DUE TO BLOOD LOSS OR AN UNSPECIFIED CARDIAC ISSUE. AN AUTOPSY WAS NOT PERFORMED. THE PATIENT'S HOSPITALIZATION WAS EXTENDED, HOWEVER, IT IS UNKNOWN IF IT WAS RELATED TO THE MYNX OR NOT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829018 MYNXGRIP 6F/7F VASCULAR CLOSURE DEVICE MGB MGB CARDINAL HEALTH MX6721 F1620905

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| H| L| R 8F TEURMO SHEATH| ASA (ASPIRIN)| HEPARIN| PLAVIX