BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN MYNX

    MDR report key: 11324109 · Received February 12, 2021

    Report

    Report Number
    3004939290-2021-02063
    Event Type
    Death
    Date Received
    February 12, 2021
    Date of Event
    December 10, 2020
    Report Date
    February 15, 2021
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    B6 (RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES) LABORATORY EXAMINATION REVEALED ACUTE SEVERE ANEMIA (HEMOGLOBIN DECREASED FROM 11.6 G/DL TO 6.0 G/DL). PHYSICAL EXAMINATION REVEALED A LARGE PALPABLE MASS OF THE LEFT ANTERIOR ABDOMINAL WALL UNDERNEATH THE SURGICAL DRAPE. NONCONTRAST ABDOMINAL CT SCAN REVEALED A LARGE HIGH-ATTENUATION MASS IN THE LEFT RECTUS ABDOMINIS MUSCLE SHEATH. PH 6.972, BASE EXCESS 26.1 MMOL/L, SERUM BICARBONATE 6.9 MMOL/L AXIAL PRECONTRAST CT (LEFT IMAGE) SHOWS A LARGE WELL-DEFINED ELLIPTICAL MASS (ARROWS) IN THE LEFT RECTUS SHEATH WITH A VARIABLE DEGREE OF HIGH ATTENUATION. THE FULL LENGTH OF THE MASS (ARROWS) CAN BE DEMARCATED ON SAGITTAL RECONSTRUCTION IMAGE (RIGHT IMAGE). B7 (OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS (E.G.,ALLERGIES,RACE,PREGNANCY,SMOKING AND ALCOHOL USE, HEPATIC/RENAL DYSFUNCTION, ETC.)) PERIPHERAL ARTERY DISEASE OF THE RIGHT LOWER EXTREMITY. BY THE TIME THE PROCEDURE WAS ALMOST FINISHED (APPROXIMATELY 2 HOURS LATER), HER FACE HAD TURNED PALE AND HER BLOOD PRESSURE HAD DECREASED (FROM 180/77 MM HG TO 74/40 MM HG). METABOLIC ACIDOSIS WORSENED IN THE SETTING OF HYPOVOLEMIC SHOCK ACIDOSIS.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE ARTICLE BY LEE HN, AN SJ, LEE WH, KIM SS, HYUN D. RECTUS SHEATH HEMATOMA ASSOCIATED WITH THE MYNX VASCULAR CLOSURE DEVICE. J VASC INTERV RADIOL. 2020 DEC 10:S1051-0443(20)30774-0. DOI: 10.1016/J.JVIR.2020.09.008. EPUB AHEAD OF PRINT. PMID: 33309456., AFTER PERCUTANEOUS ANGIOPLASTY OF THE RIGHT LOWER EXTREMITY VIA LEFT COMMON FEMORAL ACCESS, THE PATIENT DEVELOPED A LEFT RECTUS ABDOMINUS MUSCLE SHEATH HEMATOMA AND THE PATIENT EXPIRED ONE DAY POST PROCEDURE. THE DEVICE WAS USED WITH A 6F NON CORDIS SHEATH. THE OPERATOR REPORTED SUBTLE RESISTANCE DURING BALLOON INFLATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿INFLATION DIFFICULTY¿ AND ¿RETROPERITONEAL HAEMATOMA¿ COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. A RETROPERITONEAL HAEMATOMA IS A TYPE OF HEMATOMA AND DEFINED AS INTERNAL BLEEDING INTO THE RETROPERITONEAL SPACE. THIS MOST OFTEN OCCURS DUE TO A BACKWALL STICK, BUT MAY BE WORSENED WITH ANTICOAGULANT THERAPY. THERE ARE SEVERAL RISK FACTORS ASSOCIATED WITH BLEEDING COMPLICATIONS. PATIENT DEMOGRAPHIC RISK FACTORS INCLUDE ADVANCED AGE, FEMALE PATIENTS, HIGH OR LOW BMI, AND COMORBIDITIES (RENAL DISEASE, DIABETES, VASCULAR DISEASE). THIS IS A KNOWN POTENTIAL COMPLICATION OF VASCULAR PROCEDURES AND LISTED IN THE PRODUCTS INSTRUCTIONS FOR USE AS SUCH. ACCORDING TO THE INSTRUCTIONS FOR USE WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿DO NOT USE IF COMPONENTS OR PACKAGING APPEAR TO BE DAMAGED OR DEFECTIVE OR IF ANY PORTION OF THE PACKAGING HAS BEEN PREVIOUSLY OPENED.¿ AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. THE INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. LEE, H. N., AN, S. J., LEE, W. H., KIM, S. S., & HYUN, D. (2020). RECTUS SHEATH HEMATOMA ASSOCIATED WITH THE MYNX VASCULAR CLOSURE DEVICE. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY. DOI:10.1016/J.JVIR.2020.09.008. SPECIFIC PRODUCT DETAILS ARE NOT AVAILABLE. THE EXACT EVENT DATE IS UNKNOWN. THE PUBLICATION IS ATTACHED. CONCOMITANT DEVICES: 6-F VASCULAR SHEATH (RADIFOCUS INTRODUCER II.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY LEE HN, AN SJ, LEE WH, KIM SS, HYUN D. RECTUS SHEATH HEMATOMA ASSOCIATED WITH THE MYNX VASCULAR CLOSURE DEVICE. J VASC INTERV RADIOL. 2020 DEC 10:S1051-0443(20)30774-0. DOI: 10.1016/J.JVIR.2020.09.008. EPUB AHEAD OF PRINT. PMID: 33309456., AFTER PERCUTANEOUS ANGIOPLASTY OF THE RIGHT LOWER EXTREMITY VIA LEFT COMMON FEMORAL ACCESS, THE PATIENT DEVELOPED A LEFT RECTUS ABDOMINUS MUSCLE SHEATH HEMATOMA AND THE PATIENT EXPIRED ONE DAY POST PROCEDURE. THE DEVICE WAS USED WITH A 6F NON CORDIS SHEATH. THE OPERATOR REPORTED SUBTLE RESISTANCE DURING BALLOON INFLATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221311 UNKNOWN MYNX DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA UNK-MYNX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death