BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 958454 · Received December 5, 2007

    Report

    Report Number
    3004939290-2007-00015
    Event Type
    Injury
    Date Received
    December 5, 2007
    Date of Event
    November 8, 2007
    Report Date
    December 5, 2007
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE LOT NUMBER WAS NOT PROVIDED TO BE ABLE TO PERFORM LOT HISTORY REVIEW. BASED UPON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE PT EXPERIENCED HEMODYNAMIC INSTABILITY FOLLOWING A PERIPHERAL INTERVENTION IN WHICH A PERCLOSE DEVICE FAILED TO ACHIEVE HEMOSTASIS AND A MYNX DEVICE WAS SUBSEQUENTLY ATTEMPTED BY AN UNTRAINED PHYSICIAN TO ACHIEVE HEMOSTASIS. THE PHYSICIAN HAD PERFORMED 3 OUT OF 10 CASES REQUIRED TO COMPLETE THE ACI TRAINING PROGRAM, AND NO ACI REPRESENTATIVE WAS PRESENT FOR THE CASE. IN CONSIDERING POTENTIAL CAUSES, THE MULTIPLE SHEATH EXCHANGES, PERCLOSE FAILURE, AND THE SUBSEQUENT MYNX PROCEDURE ATTEMPTED BY A NEW USER WHO HAD PERFORMED LESS THAN THE 10 REQUIRED PROCTORED CASES, MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. IN ADDITION, OTHER POTENTIAL CONTRIBUTING FACTORS COULD INCLUDE THE STATUS OF THE ACCESS SITE AFTER THE PERCLOSE FAILURE INCLUDING RE-ACCESS, OOZING OR SWELLING AROUND THE SHEATH PRE-MYNX, AND THE USE OF THE MYNX DEVICE IN A PROCEDURE IN WHICH, THE STICK LOCATION WAS ABOVE THE FEMORAL HEAD. AS PER MYNX IFU, "DO NOT USE THE MYNX VASCULAR CLOSURE DEVICE IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON BONY LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA/BLEED. PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE." MYNX SHOULD ONLY BE USED BY A TRAINED LICENSED PHYSICIAN OR HEALTHCARE PROFESSIONAL.

    Description of Event or Problem · 1

    A FEMALE UNDERWENT AN UNCOMPLICATED PERIPHERAL INTERVENTION IN 2007. PRE-PROCEDURE MEDS INCLUDE ASA AND PLAVIX, ALONG WITH PERI-PROCEDURAL HEPARIN. THE STICK WAS REPORTEDLY ABOVE THE FEMORAL HEAD AND A 6F SHEATH WAS USED TO ACCESS THE CFA, WITH 2 SHEATH EXCHANGES DURING THE PROCEDURE. THE PHYSICIAN PROCEEDED TO CLOSE THE ARTERIOTOMY SITE WITH A PERCLOSE CLOSURE DEVICE, HOWEVER, THE PROCEDURE WAS UNSUCCESSFUL AND HEMOSTASIS WAS NOT ACHIEVED. THE PHYSICIAN, CURRENTLY BEING TRAINED TO THE MYNX PROCEDURE, RE-GAINED ACCESS WITH A 6F SHEATH AND ATTEMPTED CLOSURE WITH A MYNX DEVICE, HOWEVER, THE PT BECAME HEMODYNAMICALLY UNSTABLE PRIOR TO ACHIEVING HEMOSTASIS, WITH AN HCT OF 20.9 (PRE-PROCEDURE HCT REQUESTED HOWEVER NOT OBTAINED). LIMITED INFORMATION WAS PROVIDED REGARDING BLOOD LOSS OR STATUS OF THE GROIN AROUND THE PUNCTURE SITE PRE-MYNX. IT WAS UNCLEAR IF THE MYNX PROCEDURE WAS COMPLETED AND/OR PERFORMED PER IFU. THE PT WAS TREATED WITH 3 UNITS OF BLOOD, AND REPORTEDLY STABILIZED. APPROX 3.5 HRS POST PROCEDURE, HCT MEASURED 31.1. NO FURTHER MEDICATION, TREATMENT, OR THERAPEUTIC INTERVENTION WAS REQUIRED. PT WAS DISCHARGED 11/9/07 WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCULAR CLOSURE DEVICE MGB ACCESS CLOSURE, INC. MX6700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention PERI-PROCEDURAL MEDS INCLUDED HEPARIN.| PRE-PROCEDURE MEDS INCLUDED ASA AND PLAVIX.