BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYNXGRIP

    MDR report key: 22638994 · Received July 28, 2025

    Report

    Report Number
    3004939290-2025-00614
    Event Type
    Death
    Date Received
    July 28, 2025
    Date of Event
    June 9, 2025
    Report Date
    August 26, 2025
    Manufacturer
    CORDIS US CORP
    Product Code
    MGB
    UDI-DI
    10862028000410
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED, AFTER INADVERTENTLY CANNULATING THE RIGHT COMMON FEMORAL VEIN (CFV), A 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WAS USED TO SEAL THE VEIN. POST-PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA. A FEMORAL COMPRESSION DEVICE WAS APPLIED, BUT THE HEMATOMA PERSISTED. SURGICAL INTERVENTION WAS REQUIRED; THE SURGEON DRAINED THE HEMATOMA AND DISCOVERED A TEAR IN THE VEIN, WHICH WAS THEN REPAIRED. UNFORTUNATELY, THE PATIENT LATER EXPIRED. A PHYSICIAN WAS PERFORMING A PERCUTANEOUS CORONARY INTERVENTION (PCI) ON A PATIENT WITH MULTIPLE COMORBIDITIES. DURING AN ATTEMPT TO ACCESS THE RIGHT COMMON FEMORAL ARTERY (CFA), THE PHYSICIAN INADVERTENTLY CANNULATED THE RIGHT COMMON FEMORAL VEIN (CFV). SUBSEQUENTLY, THE PHYSICIAN ACCESSED THE LEFT COMMON FEMORAL ARTERY (CFA) AND PROCEEDED WITH THE INTERVENTION. THE HOSPITAL IS CURRENTLY CONDUCTING A ROOT CAUSE ANALYSIS OF THE EVENT. ALTHOUGH THEY DO NOT ATTRIBUTE THE ADVERSE OUTCOME TO THE USE OF THE MYNXGRIP DEVICE, THEY HAVE NOTIFIED US DUE TO THE ONGOING INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F2501602 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. ACCESS SITE HEMATOMAS/HEMORRHAGES ARE A COMMON POST-PROCEDURAL COMPLICATION AND ARE LISTED IN THE PRODUCT¿S INSTRUCTIONS FOR USE (IFU) AS SUCH. BLEEDING EVENTS ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE, ADEQUATE SHEATH/DEVICE REMOVAL TECHNIQUE, THE PROPER PLACEMENT OF THE VCD SEALANT, AND THE PATIENT'S COMPLIANCE TO DECREASE MOBILITY OF LIMB AFFECTED IN ORDER TO PROMOTE COAGULATION. ACCESS SITE BLEEDING EVENTS CAN REQUIRE PROLONGED MANUAL COMPRESSION, BLOOD TRANSFUSION, OR EVEN SURGICAL INTERVENTION. BASED ON THE AVAILABLE INFORMATION, THE HEMATOMA MAY HAVE BEEN CAUSED BY THE VEIN TEAR NOTED WHEN THE HEMATOMA WAS DRAINED. A VASCULAR INJURY, SUCH AS A TEAR, OCCURRING DURING A CATHETERIZATION PROCEDURE IS A KNOWN POTENTIAL COMPLICATION AND IS ALSO LISTED IN THE MYNXGRIP IFU. AS IT WAS REPORTED THAT THE COMMON FEMORAL VEIN WAS INADVERTENTLY ACCESSED, THE INJURY MAY HAVE RESULTED FROM STICK TECHNIQUE, SUCH AS A BACKWALL STICK. REGARDING THE REPORTED PATIENT DEATH, THIS OUTCOME IS ALSO LISTED IN THE IFU AS A POTENTIAL COMPLICATION. HOWEVER, AS THE CAUSE OF DEATH WAS NOT PROVIDED, THE RELATIONSHIP TO THE MYNXGRIP DEVICE OR THE HEMATOMA/VASCULAR INJURY COULD NOT BE DETERMINED. ALTHOUGH THE CUSTOMERS DID NOT ATTRIBUTE THE OUTCOME TO THE DEVICE, A DEVICE-RELATED CONTRIBUTION CANNOT BE RULED OUT WITH THE LIMITED INFORMATION PROVIDED. AS IMAGES OF THE PATIENT¿S CONDITIONS WERE NOT PROVIDED, THE COMPLAINTS COULD NOT BE OBSERVED. FURTHERMORE, WITHOUT RETURN OF THE DEVICE, PRODUCT-RELATED CONTRIBUTING FACTORS COULD NOT BE DETERMINED. AS WARNED IN THE IFU, WHICH IS NOT INTENDED AS A MITIGATION, ¿IN ADDITION TO THE COMPLICATIONS NOTED IN THE MYNX CLINICAL TRIAL, THE FOLLOWING POTENTIAL COMPLICATIONS, WHICH MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE VASCULAR CLOSURE, MAY OCCUR: ALLERGIC REACTION, ECCHYMOSIS, SUPERFICIAL VEIN THROMBOSIS, FOREIGN BODY/LOCAL REACTION, RETROPERITONEAL BLEED, VESSEL OCCLUSION, PULMONARY EMBOLISM, OR DEATH.¿ NEITHER THE PHR REVIEW, NOR THE AVAILABLE INFORMATION SUGGESTS THAT THE ISSUES EXPERIENCED COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, AFTER INADVERTENTLY CANNULATING THE RIGHT COMMON FEMORAL VEIN (CFV), A 6/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WAS USED TO SEAL THE VEIN. POST-PROCEDURE, THE PATIENT DEVELOPED A HEMATOMA. A FEMORAL COMPRESSION DEVICE WAS APPLIED, BUT THE HEMATOMA PERSISTED. SURGICAL INTERVENTION WAS REQUIRED; THE SURGEON DRAINED THE HEMATOMA AND DISCOVERED A TEAR IN THE VEIN, WHICH WAS THEN REPAIRED. UNFORTUNATELY, THE PATIENT LATER EXPIRED. A PHYSICIAN WAS PERFORMING A PERCUTANEOUS CORONARY INTERVENTION (PCI) ON A PATIENT WITH MULTIPLE COMORBIDITIES. DURING AN ATTEMPT TO ACCESS THE RIGHT COMMON FEMORAL ARTERY (CFA), THE PHYSICIAN INADVERTENTLY CANNULATED THE RIGHT COMMON FEMORAL VEIN (CFV). SUBSEQUENTLY, THE PHYSICIAN ACCESSED THE LEFT COMMON FEMORAL ARTERY (CFA) AND PROCEEDED WITH THE INTERVENTION. THE HOSPITAL IS CURRENTLY CONDUCTING A ROOT CAUSE ANALYSIS OF THE EVENT. ALTHOUGH THEY DO NOT ATTRIBUTE THE ADVERSE OUTCOME TO THE USE OF THE MYNX GRIP DEVICE, THEY HAVE NOTIFIED US DUE TO THE ONGOING INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475898 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP F2501602 10862028000410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L FEMORAL COMPRESSION DEVICE (FEM-STOP)| UNKNOWN SHEATH