BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 6028896 · Received October 13, 2016

    Report

    Report Number
    3004939290-2016-00276
    Event Type
    Injury
    Date Received
    October 13, 2016
    Report Date
    September 19, 2016
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION WAS NOT PERFORMED. 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. ADDITIONALLY, USERS ARE INSTRUCTED TO APPLY ADDITIONAL COMPRESSION AS NECESSARY IF HEMOSTASIS IS NOT ACHIEVED. 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 (F1616601) INDICATED THAT THERE WERE NO REWORKS OR RELATED NON-CONFORMANCES (NCMRS) FOR THIS LOT. THE 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; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IT WAS REPORTED THAT THE PATIENT HAD A BAD COUGH AND A COUGHING FIT CAUSED THE SEALANT TO DISLODGE FROM THE VESSEL. THE MYNXGRIP PATIENT BROCHURE ADVISES PATIENTS MODIFY ACTIVITIES FOR A MINIMUM OF 3 DAYS FOLLOWING CLOSURE. THE PATIENT BROCHURE INSTRUCTS PATIENTS TO SUPPORT GROIN BY PRESSING WITH THE PALM ON TOP OF THE DRESSING/BANDAGE WHEN COUGHING, SNEEZING, OR STRAINING FOR A BOWEL MOVEMENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED. THIS IS REPORT 2 OF 2; FROM THE SAME USER FACILITY SAME LOT NUMBER AS MFR REPORT #: 3004939290-2016-00275.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING 2 DIFFERENT PROCEDURES WITH 2 MYNXGRIP DEVICES FROM THE SAME LOT, 2 DIFFERENT PATIENTS DEVELOPED A HEMATOMA LARGER THAN 6 CM IN SIZE. THIS REPORT IS FOR EVENT 2 OF 2. THE MYNXGRIP 6F/7F VASCULAR CLOSURE DEVICE WAS BEING USED FOLLOWING AN UNSPECIFIED PROCEDURE. THE DEVICE WAS DEPLOYED SUCCESSFULLY AND HEMOSTASIS WAS ACHIEVED. IT WAS REPORTED THAT THE PATIENT HAD A BAD COUGH AND A FEW HOURS LATER, THE PATIENT HAD A COUGHING FIT AND FELT THE CLOSURE DEVICE "POP", BUT DID NOT ALERT THE NURSING STAFF. THE HEMATOMA WAS RESOLVED WITH MANUAL COMPRESSION WHICH WAS APPLIED FOR GREATER THAN 30 MINUTES TO STOP THE BLEEDING. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679376 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB CARDINAL HEALTH MX6721 F1616601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention