BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX ACE (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 5222012 · Received November 13, 2015

    Report

    Report Number
    3004939290-2015-00518
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 21, 2015
    Report Date
    October 21, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED COMPLAINT WAS RETURNED TO ACCESSCLOSURE, INC. (A CARDINAL HEALTH COMPANY), AND THE SHEATH KINK (MYNX ACE) WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE INTRODUCER SHEATH WAS KINKED 28 MM FROM THE DISTAL END. SEVERE KINK IN THE INTRODUCER SHEATH MAY HAVE OBSTRUCTED THE DEVICE PATH DURING THE CATHETER INSERTION. IT WAS REPORTED THAT THERE WAS PRIOR CATHETERIZATION/SCAR TISSUE ON THE PUNCTURE SITE. THE SCAR TISSUE ON THE PUNCTURE SITE MAY HAVE CAUSED THE DIFFICULTY FOR THE INTRODUCER SHEATH TO MAKE THE TURN INTO THE VESSEL. INVESTIGATION REVEALED THAT BUTTON #2 HAD BEEN DEPRESSED BUT BUTTON #3 (FOR BALLOON RETRACTION) WAS NOT RETRACTED. IF THE BALLOON WHICH IS LOCATED RIGHT AT THE DISTAL TIP OF THE ADVANCER TUBE IS NOT RETRACTED INTO THE ADVANCER TUBE, THE BALLOON MAY DRAG THE SEALANT FROM ABOVE THE ARTERIOTOMY DURING CATHETER REMOVAL. THE SEALANT WAS SEPARATED FROM THE RETURNED DEVICE AND SOAKED IN BLOOD. THE SEALANT WAS MOISTENED WITH WATER DURING INVESTIGATION AND THE SEALANT SWELLED SIGNIFICANTLY WHEN HYDRATED. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE OF THE REPORTED DIFFICULTY IN ADVANCING THE MYNX ACE VASCULAR CLOSURE DEVICE SHEATH INTO THE ARTERY COULD HAVE BEEN THE SCAR TISSUE ON THE PUNCTURE SITE FROM PRIOR CATHETERIZATION. IT SHOULD BE NOTED THAT THE INSTRUCTION FOR USE (IFU) STATES: THE SAFETY AND EFFECTIVENESS OF THE MYNX VASCULAR CLOSURE DEVICE HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH PRIOR SURGICAL PROCEDURE, PTA, STENT PLACEMENT, OR VASCULAR GRAFT IN THE COMMON FEMORAL ARTERY. THE PROBABLE CAUSE OF THE DISLODGED SEALANT COULD HAVE BEEN THE BALLOON NOT FULLY RETRACTED. THE PROBABLE CAUSE OF THE REPORTED HEMATOMA COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1507201) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: THIS WAS A DIAGNOSTIC NEURO PROCEDURE. A GROIN SHOT WAS TAKEN AND THE STICK WAS FOUND TO BE BELOW THE FEMORAL HEAD. THE PATIENT DID HAVE CALCIUM/PVD HIGHER IN THE EXTERNAL ILIAC, BUT THE STICK WAS IN THE COMMON FEMORAL ARTERY. THE PATIENT WAS ON ASPIRIN AND PLAVIX. THE PHYSICIAN HAD NO ISSUES INSERTING THE DIAGNOSTIC PROCEDURAL SHEATH (PER THE RADIOLOGY TECHNOLOGIST). THE PHYSICIAN DID NOT MAKE A SKIN NICK UPON INSERTION OF THE DIAGNOSTIC PROCEDURAL SHEATH. FOR THE DEPLOYMENT (DURING SHEATH EXCHANGE), THE RADIOLOGY TECHNOLOGIST MADE A SMALL NICK AFTER FINDING SOME RESISTANCE TO INTRODUCING THE MYNX ACE VASCULAR CLOSURE DEVICE SHEATH. INSERTED THE MYNX ACE VASCULAR CLOSURE DEVICE WITH SOME RESISTANCE AS WELL. THE DEPLOYER WAS FINALLY ABLE TO CONNECT THE BLACK HOUSING TO THE MYNX ACE VASCULAR CLOSURE DEVICE SHEATH AND CONTINUED WITH NORMAL DEPLOYMENT. UPON LAYING THE DEVICE DOWN AFTER PRESSING BUTTON #2, A MEDIUM AMOUNT OF SEALANT WAS NOTED OUTSIDE THE INCISION SITE. NO BLEEDING OR HEMATOMA WAS NOTED. REMOVED THE DEVICE AFTER 2 MINUTES AND IMMEDIATELY HELD FIRM PRESSURE FOR 2 MINUTES. UPON RELEASING PRESSURE, SEALANT WAS NOTED SITTING AT THE INCISION SITE. UNSURE WHETHER ALL THE SEALANT WAS EXPOSED OR IF THERE WAS STILL SOME AT THE ARTERIOTOMY AS NO HEMATOMA OR BLEEDING WAS NOTED, BUT AFTER 5 SECONDS, THE SITE STARTED TO OOZE SLIGHTLY. THE GROIN ALWAYS FELT SOFT AND SQUISHY PER THE RADIOLOGY TECHNOLOGIST. A HEMATOMA OF 6 CM OR LESS WAS OBSERVED. THE RADIOLOGY TECHNOLOGIST IMMEDIATELY HELD PRESSURE FOR 10 MORE MINUTES. THE GROIN WAS MAINTAINED AND DRESSED IN A NORMAL FASHION. NO ANTIBIOTIC WAS GIVEN. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION: THERE WERE VISIBLE KINKS IN THE SHEATH AFTER REMOVAL. THERE WAS PRIOR CATHETERIZATION/SCAR TISSUE ON THE PUNCTURE SITE. THE BALLOON WAS FULLY DEFLATED. BUTTON #3 WAS COMPLETELY RETRACTED. FINGERTIP COMPRESSION WAS HELD DURING THE DEVICE REMOVAL. PROCEDURE TYPE: DIAGNOSTIC PERIPHERAL STICK LOCATION: MEDIUM SHEATH SIZE: 6F VESSEL SIZE: 5 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751706 MYNX ACE (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB CARDINAL HEALTH MX6740 F1507201

    Patients

    Seq Age Sex Outcome Treatment
    1