BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 2853080 · Received August 7, 2012

    Report

    Report Number
    3004939290-2012-00256
    Event Type
    Injury
    Date Received
    August 7, 2012
    Date of Event
    July 12, 2012
    Report Date
    July 12, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1211608) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI CLINICAL SPECIALIST THAT A (B)(6) FEMALE PT, WEIGHING (B)(6), UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE FEMORAL HEAD, VIA A 7F SHEATH (UNK MODEL) IN THE RIGHT COMMON FEMORAL ARTERY. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NOMINAL AMOUNT OF PVD/CALCIUM PRESENT IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL TO BE APPROXIMATELY 6 MM IN SIZE. PRE-PROCEDURE THE PT WAS ANTI-COAGULATED WITH ASPIRIN AND 7,000 UNITS OF HEPARIN. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS PREPPED AND DEPLOYED ACCORDING TO THE IFU. POST DEVICE REMOVAL THE CLINICAL SPECIALIST INSTRUCTED THE PHYSICIAN TO HOLD THE SITE FOR 5 MINUTES DUE TO 3 SHEATH EXCHANGED, 7,000 UNITS OF HEPARIN, AND HAVING A 7F SHEATH IN PLACE. DURING THE INITIAL 5 MINUTE HOLD, THE PHYSICIAN BEGAN MASSAGING THE SITE, AND THE CLINICAL SPECIALIST INSTRUCTED THE PHYSICIAN NOT TO DO THAT, AS IT COULD POTENTIALLY DISLODGE THE SEALANT. AFTER THE 5 MINUTES OF PRESSURE, THE PHYSICIAN SQUEEZED THE SITE, AND THE SITE BEGAN TO OOZE. THE PHYSICIAN CONTINUED TO SQUEEZE AND COMPRESS THE SITE FOR AN ADDITIONAL 5 MINUTES. THE DRAPE WAS REMOVED AND A LOW INFERIOR HEMATOMA APPROXIMATELY 8 CM HAD DEVELOPED AT THE SITE. PRESSURE WAS THEN HELD FOR 10 MINUTES, WHILE THE PT RECOVERED FROM ANESTHESIA, ONCE THE PT WAS AWAKE A FEMOSTOP WAS APPLIED. THE PHYSICIAN UNDERSTOOD THE HEMATOMA LIKELY DEVELOPED FROM MASSAGING THE SITE AND POTENTIALLY DISLODGING THE SEALANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F MGB ACCESSCLOSURE, INC. MX6701 F1211608

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ASPIRIN| 7,00 UNITS OF HEPARIN