BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN MYNXGRIP

    MDR report key: 12374107 · Received August 26, 2021

    Report

    Report Number
    3004939290-2021-02306
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Report Date
    August 26, 2021
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE IS UNKNOWN AS THIS EVENT IS FROM A LITERATURE ARTICLE. AS REPORTED IN THE LITERATURE ARTICLE BY MIRANDA MD, J.A., PALLISTER MD, Z., HANSRAJ MD, N., AND MONTERO-BAKER MD, M. (2021), DUPLEX-ULTRASOUND ASSISTED MYNX CLOSURE OF SUPERFICIAL FEMORAL ARTERY ANTEGRADE ACCESS FOLLOWING LOWER-EXTREMITY ENDOVASCULAR INTERVENTION, JOURNAL OF CRITICAL LIMB ISCHEMIA, VOLUME 1, PG 1-6, HTTPS://WWW.HMPGLOBALLEARNINGNETWORK.COM/SITE/CLIJOURNAL/ORIGINAL-CONTRIBUTION/DUPLEX-ULTRASOUND-ASSISTED-MYNX-CLOSURE-SUPERFICIAL-FEMORAL, AN UNKNOWN MYNXGRIP FAILED TO ACHIEVE HEMOSTASIS. MANUAL COMPRESSION WAS SUCCESSFULLY APPLIED. HOWEVER, A LARGE HEMATOMA DEVELOPED IN THE AREA ALONG THE SARTORIUS MUSCLE. ULTRASOUND DEMONSTRATED NO FURTHER HEMORRHAGE FROM THE ACCESS SITE FOLLOWING PROLONGED ULTRASOUND-GUIDED COMPRESSION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, AND THE LIMB WAS SUCCESSFULLY REVASCULARIZED. DUPLEX ULTRASONOGRAPHY ON POSTOPERATIVE DAY 1 REVEALED NO EVIDENCE OF PSEUDOANEURYSM AND THE PATIENT HAD A STABLE HEMOGLOBIN AND HEMATOCRIT COMPARED WITH HIS PREOPERATIVE LEVELS. NO FURTHER INTERVENTION WAS REQUIRED. THE PROCEDURE USED AN IPSILATERAL, ANTEGRADE APPROACH OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE MYNX BALLOON WAS PREPPED WITH A 50:50 CONTRAST: SALINE RATIO. THE MYNX DEVICE WAS INTRODUCED, AND THE BALLOON WAS INFLATED UNDER ULTRASOUND GUIDANCE. ACT WAS MAINTAINED AT <180 SECONDS AND SYSTOLIC BLOOD PRESSURE WAS <180MMHG. THE DEVICE AND THE SHEATH WERE SLOWLY RETRACTED TO THE ARTERIOTOMY SITE UNDER CONSTANT ULTRASOUND VISUALIZATION. WHEN INTRALUMINAL ANTERIOR WALL APPOSITION OF THE BALLOON WAS SEEN ON ULTRASOUND, THE POLYETHYLENE GLYCOL PLUG WAS DEPLOYED. TENSION WAS HELD AND THEN THE PLUG WAS RELEASED PER THE DEVICE INSTRUCTIONS FOR USE (IFU). FOLLOWING THE REQUISITE DEPLOYMENT STEPS, ADDITIONAL ULTRASOUND-GUIDED PRESSURE OVER THE ARTERIOTOMY SITE AND SHEATH TRACT WAS PERFORMED FOR 5 MINUTES. 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 ¿SEALANT -FAILURE TO ACHIEVE HEMOSTASIS¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HEMATOMA DEVELOPMENT IS A KNOWN ADVERSE EVENT ASSOCIATED WITH FEMORAL ACCESS SITES AND/OR THE USE OF A VASCULAR CLOSURE DEVICE AND IS LISTED AS SUCH IN THE INSTRUCTION FOR USE (IFU). THE MYNXGRIP IFU WARNS: DO NOT USE MYNXGRIP IF THE PUNCTURE SITE IS LOCATED ABOVE THE MOST INFERIOR BORDER OF THE INFERIOR EPIGASTRIC ARTERY (IEA) (FOR ARTERIAL APPLICATION) AND/OR ABOVE THE INGUINAL LIGAMENT BASED UPON OSSEUS LANDMARKS, SINCE SUCH A PUNCTURE SITE MAY RESULT IN A RETROPERITONEAL HEMATOMA/BLEED. PERFORM A FEMORAL ANGIOGRAM OR VENOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. DO NOT USE MYNXGRIP IF THE PUNCTURE IS THROUGH THE POSTERIOR WALL OR IF THERE ARE MULTIPLE PUNCTURES, AS SUCH PUNCTURES MAY RESULT IN A RETROPERITONEAL HEMATOMA/BLEED. WITH THE LIMITED INFORMATION PROVIDED, AN EXACT CAUSE FOR THE EVENTS COULD NOT BE DETERMINED, HOWEVER, PROCEDURAL AND/OR PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ¿HEMATOMA¿. 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.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY MIRANDA MD, J.A., PALLISTER MD, Z., HANSRAJ MD, N., AND MONTERO-BAKER MD, M. (2021), DUPLEX-ULTRASOUND ASSISTED MYNX CLOSURE OF SUPERFICIAL FEMORAL ARTERY ANTEGRADE ACCESS FOLLOWING LOWER-EXTREMITY ENDOVASCULAR INTERVENTION, JOURNAL OF CRITICAL LIMB ISCHEMIA, VOLUME 1, PG 1-6, HTTPS://WWW.HMPGLOBALLEARNINGNETWORK.COM/SITE/CLIJOURNAL/ORIGINAL-CONTRIBUTION/DUPLEX-ULTRASOUND-ASSISTED-MYNX-CLOSURE-SUPERFICIAL-FEMORAL, AN UNKNOWN MYNXGRIP FAILED TO ACHIEVE HEMOSTASIS. MANUAL COMPRESSION WAS SUCCESSFULLY APPLIED. HOWEVER, A LARGE HEMATOMA DEVELOPED IN THE AREA ALONG THE SARTORIUS MUSCLE. ULTRASOUND DEMONSTRATED NO FURTHER HEMORRHAGE FROM THE ACCESS SITE FOLLOWING PROLONGED ULTRASOUND-GUIDED COMPRESSION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, AND THE LIMB WAS SUCCESSFULLY REVASCULARIZED. DUPLEX ULTRASONOGRAPHY ON POSTOPERATIVE DAY 1 REVEALED NO EVIDENCE OF PSEUDOANEURYSM AND THE PATIENT HAD A STABLE HEMOGLOBIN AND HEMATOCRIT COMPARED WITH HIS PREOPERATIVE LEVELS. NO FURTHER INTERVENTION WAS REQUIRED. THE PROCEDURE USED AN IPSILATERAL, ANTEGRADE APPROACH OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE MYNX BALLOON WAS PREPPED WITH A 50:50 CONTRAST: SALINE RATIO. THE MYNX DEVICE WAS INTRODUCED, AND THE BALLOON WAS INFLATED UNDER ULTRASOUND GUIDANCE. ACT WAS MAINTAINED AT <180 SECONDS AND SYSTOLIC BLOOD PRESSURE WAS <180MMHG. THE DEVICE AND THE SHEATH WERE SLOWLY RETRACTED TO THE ARTERIOTOMY SITE UNDER CONSTANT ULTRASOUND VISUALIZATION. WHEN INTRALUMINAL ANTERIOR WALL APPOSITION OF THE BALLOON WAS SEEN ON ULTRASOUND, THE POLYETHYLENE GLYCOL PLUG WAS DEPLOYED. TENSION WAS HELD AND THEN THE PLUG WAS RELEASED PER THE DEVICE INSTRUCTIONS FOR USE (IFU). FOLLOWING THE REQUISITE DEPLOYMENT STEPS, ADDITIONAL ULTRASOUND-GUIDED PRESSURE OVER THE ARTERIOTOMY SITE AND SHEATH TRACT WAS PERFORMED FOR 5 MINUTES. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270308 UNKNOWN MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA UNK-MYNXGRIP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR