BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MYNX

    MDR report key: 7870426 · Received September 12, 2018

    Report

    Report Number
    3004939290-2018-00754
    Event Type
    Injury
    Date Received
    September 12, 2018
    Date of Event
    July 18, 2013
    Report Date
    September 12, 2018
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN A LITERATURE PUBLICATION BY GRANDHI ET AL., (JULY 18, 2013). SAFETY AND EFFICACY OF PERCUTANEOUS FEMORAL ARTERY ACCESS FOLLOWED BY MYNX CLOSURE IN CEREBRAL NEUROVASCULAR PROCEDURES: A SINGLE CENTER ANALYSIS. J NEUROINTERVENT SURG 2014; 6:445¿450; REPORT FOUR PATIENTS DEVELOPED GROIN HEMATOMAS. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. ACCESS SITE HEMATOMAS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE, ADEQUATE SHEATH REMOVAL TECHNIQUE AND THE PATIENT'S COMPLIANCE TO DECREASE MOBILITY OF THE LIMB AFFECTED IN ORDER TO PROMOTE COAGULATION. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICES AND THE EVENTS REPORTED. PATIENT /OR PHARMACOLOGICAL FACTORS ARE LIKELY CONTRIBUTING FACTORS TO THE HEMATOMAS REPORTED. THE COMPLAINT REPORTED COULD NOT BE CONFIRMED. ACCORDING TO THE PRODUCT INSTRUCTION FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION, PROLONGED ACCESS SITE-RELATED BLEEDING IS A POTENTIAL RISK ASSOCIATED WITH FEMORAL ARTERY CLOSURE PROCEDURES. IT IS STATED THAT THE SAFETY AND EFFECTIVENESS OF MYNXGRIP HAVE NOT BEEN ESTABLISHED IN THE PATIENTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE IN THE VICINITY OF THE PUNCTURE. 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 A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. GRANDHI, R., KANAAN, H., SHAH, A., HARRISON, G., BONFIELD, C., JOVIN, T., . . . HOROWITZ, M. (2013). SAFETY AND EFFICACY OF PERCUTANEOUS FEMORAL ARTERY ACCESS FOLLOWED BY MYNX CLOSURE IN CEREBRAL NEUROVASCULAR PROCEDURES: A SINGLE CENTER ANALYSIS. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 6(6), 445-450. DOI:10.1136/NEURINTSURG-2013-010749 THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICES ARE MYNX BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    AS NOTED IN A LITERATURE PUBLICATION BY GRANDHI ET AL., (JULY 18, 2013). SAFETY AND EFFICACY OF PERCUTANEOUS FEMORAL ARTERY ACCESS FOLLOWED BY MYNX CLOSURE IN CEREBRAL NEUROVASCULAR PROCEDURES: A SINGLE CENTER ANALYSIS. J NEUROINTERVENT SURG 2014; 6:445¿450; REPORT FOUR PATIENTS DEVELOPED GROIN HEMATOMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708995 UNKNOWN MYNX DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L