BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2241962 · Received September 9, 2011

    Report

    Report Number
    3004939290-2011-00198
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 15, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 F1102505) DID NOT EXHIBIT ANY ISSUE THAT SUGGESTS THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL WHO WAS PRESENT AT THE ACCOUNT WHEN A MALE PATIENT ON DIALYSIS FOR RENAL FAILURE UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE ON (B)(6) 2011. ACCESS WAS OBTAINED AT THE RIGHT COMMON FEMORAL ARTERY VIA AN UNKNOWN SIZE PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM WAS UNREMARKABLE FOR CALCIUM OR PERIPHERAL VASCULAR DISEASE IN THE VICINITY OF THE ACCESS SITE. THE PATIENT WAS GIVEN ANGIOMAX PERI-PROCEDURE. POST PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE TO CLOSE THE FEMORAL ARTERY. THERE WAS NO REPORT OF COMPLICATION DURING THE PROCEDURE OR CLOSURE. FOLLOWING THE PROCEDURE, THE PATIENT WAS SENT TO AN ALREADY SCHEDULED DIALYSIS. REPORTEDLY, THE CORONARY CATH LAB (CCL) STAFF RECEIVED A PHONE CALL FROM THE DIALYSIS DEPARTMENT THAT THE PATIENT HAD DEVELOPED A LARGE HEMATOMA (UNKNOWN HOW LONG AFTER PROCEDURE), AND SINCE THE ACI SALES PROFESSIONAL WAS STILL THERE, WAS ASKED TO LOOK AT THE HEMATOMA. WHEN THE SALES PROFESSIONAL GOT TO THE PATIENT'S ROOM, THE NURSE WAS NO LONGER HOLDING PRESSURE ON THE ACCESS SITE BUT WAS STATING THAT THE HEMATOMA WAS UNDER CONTROL AND THERE WAS A LINE DRAWN ON THE SKIN AROUND THE HEMATOMA TO SHOW ITS SIZE. UPON EXAMINATION OF THE GROIN, THE ACI SALES PROFESSIONAL REPORTED THAT THERE WAS A "HALF-PALM" SIZE HEMATOMA THAT WAS "MARKED" AND STABILIZED. THE PATIENT STAYED OVERNIGHT AT THE HOSPITAL PER STANDARD PROTOCOL FOR INTERVENTION PROCEDURES AND WAS DISCHARGED TO HOME THE FOLLOWING DAY WITH NO PATIENT CLINICAL SEQUELA REPORTED. UPON FOLLOW-UP WITH THE PHYSICIAN, THE ACI SALES PROFESSIONAL REPORTED THAT THE PHYSICIAN STATED THAT THE HEMATOMA WAS MOST LIKELY DUE TO THE FACT THAT THE PATIENT'S RENAL FAILURE MADE THE PATIENT A HIGH RISK FOR BLEEDING. ADDITIONALLY, ANTICOAGULANTS ADMINISTERED PERI-PROCEDURE STAY IN THE BODY LONGER IN RENAL FAILURE PATIENTS. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2011, THE ACI SALES PROFESSIONAL CONFIRMED THAT MANUAL COMPRESSION WAS USED TO CONTROL THE BLEEDING AND TREAT THE HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6701 F1102505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANGIOMAX