BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MYNX

    MDR report key: 7872489 · Received September 13, 2018

    Report

    Report Number
    3004939290-2018-00756
    Event Type
    Injury
    Date Received
    September 13, 2018
    Date of Event
    July 18, 2013
    Report Date
    September 13, 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

    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. 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 AS A RESULT OF A MINOR COMPLICATION, ONE PATIENT HAD A FEMORAL ARTERY DISSECTION MANAGED NON-OPERATIVELY. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. VESSEL DAMAGE, SUCH AS A DISSECTION, IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY PROCEDURE IN WHICH MULTIPLE DEVICES ARE INTRODUCED INTO THE PATIENT. THE INTRODUCTION OF THE SHEATH, STIFF GUIDEWIRES, BALLOONS, CATHETERS, AND STENTS, AS WELL AS THE MYNXGRIP DEVICE COULD HAVE LED TO THE FEMORAL ARTERY DISSECTION REPORTED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICES AND THE EVENTS REPORTED. HOWEVER, HANDLING FACTORS ARE LIKELY. THE COMPLAINT REPORTED COULD NOT BE CONFIRMED. ACCORDING TO THE PRODUCT INSTRUCTION FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION, 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.

    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 AS A RESULT OF A MINOR COMPLICATION, ONE PATIENT HAD A FEMORAL ARTERY DISSECTION MANAGED NON-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714632 UNKNOWN MYNX DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| S