BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

    MDR report key: 20646816 · Received November 9, 2024

    Report

    Report Number
    3010024164-2024-00008
    Event Type
    Injury
    Date Received
    November 9, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 22, 2024
    Manufacturer
    RECOR MEDICAL, INC.
    Product Code
    QYI
    PMA / PMN Number
    P220023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES USED IN THIS PROCEDURE WERE NOT RETURNED TO RECOR FOR EVALUATION. THE ISSUES NOTED OCCURRED PRIOR TO THE RECOR DEVICES BEING INTRODUCED TO THE PATIENT. THE ISSUE WAS RELATED TO THE NON-RECOR GUIDE CATHETER WHEN IT WAS INTRODUCED TO THE PATIENT.

    Additional Manufacturer Narrative · 0

    THE EXACT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THERE IS NO INDICATION OF ANY FAILURE OF THE DEVICE. IN ADDITION, THERE IS NO INDICATION OF ANY MISUSE OF THE DEVICE. EVENT: VASCULAR PSEUDOANEURYSM. 61-YEAR-OLD FEMALE ENROLLED IN RADIANCE DUO ON (B)(6) 2024. PAST MEDICAL HISTORY WAS SIGNIFICANT FOR CONSTIPATION, THYROID TUMOR AND COXARTHROSIS. SUBJECT WAS ON TWO ANTIHYPERTENSIVE MEDICATIONS AT THE TIME OF CONSENT. ON (B)(6) 2024, THE SUBJECT UNDERWENT RENAL DENERVATION PROCEDURE, AND THE PROCEDURE WAS UNEVENTFUL. POST PROCEDURE SUBJECT WAS STABLE WITH NORMAL VITAL SIGNS. ON (B)(6)2024, 1 DAY POST-PROCEDURE, SUBJECT'S PRE-AMBULATION BP WAS FOUND 112/67MMHG WHICH REDUCED TO 96/55 MMHG AFTER AMBULATION. THE SUBJECT COMPLAINED OF RIGHT LOWER ABDOMINAL PAIN AND COLD SWEATS. SUBJECT'S BLOOD PRESSURE FURTHER DROPPED TO 72/38 MMHG, HR: 95 BPM WITHIN THE NEXT 3 HOURS. ON EXAMINATION, THE SUBJECT APPEARED PALE WITH PALPEBRAL CONJUNCTIVAL ANEMIA AND HAD IMPAIRED CONSCIOUSNESS HOWEVER, NO SIGNS OF VISIBLE BLEEDING OR HEMATOMA AT THE PUNCTURE SITE WERE NOTED. SOLULACT INFUSION AND VASOPRESSORS WERE INITIATED TO MAINTAIN BLOOD PRESSURE. A CONTRAST CT SCAN WAS PERFORMED, WHICH NOTED INJURY TO THE RIGHT EXTERNAL ILIAC ARTERY AND PSEUDOANEURYSM. THE SUBJECT'S BP REMAINED LOW 78/43 MMHG, HR: 82 BPM AFTER 1 HOUR. CONSEQUENTLY, AN EMERGENCY INTERVENTIONAL RADIOLOGY PROCEDURE WAS PERFORMED. SUBJECT WAS TREATED WITH VIABAHN STENT (8.0MM/ 50MM) IMPLANTATION IN INJURED PART OF RIGHT EXTERNAL ILIAC ARTERY. THE SUBJECT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. WHILE IN ICU, SUBJECTS ANEMIA PROGRESSED WITH HB DROPPING TO 8.6G/DL, CONSEQUENTLY BLOOD TRANSFUSION WAS INITIATED. ON (B)(6)2024, THE ANTIHYPERTENSIVE DRUG: TERAMURO (TELMISARTAN AND AMLODIPINE BESILATE) WAS SUSPENDED. THE SUBJECT'S SYSTOLIC BP INCREASED TO 110-140 MMHG, HR: 90 BPM. ON ABDOMINAL EXAMINATION, THE SUBJECT HAD SEVERE TENDERNESS IN THE RIGHT LOWER ABDOMEN. ON (B)(6) 2024, A CONTRAST CT SCAN WAS PERFORMED TO MONITOR HEMOSTASIS AFTER TREATING THE PSEUDOANEURYSM, WHICH NOTED A RETROPERITONEAL HEMATOMA. THE SUBJECT'S VITALS WERE STABILIZED, TERAMURO THERAPY WAS RESUMED, PAIN WAS CONTROLLED. ON (B)(6) 2024, THE SUBJECT'S SPO2 DROPPED FROM 95% TO 90% (ON OXYGEN SUPPLEMENTATION AT 6 L/MIN). ON (B)(6) 2024, SIGNS OF ANEMIA WERE IMPROVING HOWEVER, THE SUBJECT DEVELOPED ATELECTASIS AND PLEURAL EFFUSION DUE TO FLUID OVERLOAD CAUSED BY MASSIVE FLUID INFUSION TO TREAT HEMORRHAGIC SHOCK. NO SIGNS OF INFECTION WERE FOUND. AZOSEMIDE AND TOLVAPTAN STARTED TO TREAT PLEURAL EFFUSION. ON (B)(6) 2024, THE SUBJECT WAS TRANSFERRED FROM ICU TO GENERAL WARD, OXYGEN SATURATION WAS NOTED 90% (OXYGEN AT 4 L/MIN). ON (B)(6) 2024, A CT WAS PERFORMED, WHICH SHOWED NO EVIDENCE OF CONTRAST LEAKAGE, ASCITES WAS DECREASED, NO REPORTED SIGNIFICANT CHANGE IN SIZE OF HEMATOMA OR ACTIVE BLEEDING. WITH THE SUSPICION OF URINARY TRACT INFECTION, ANTIBIOTICS WERE STARTED. SUBJECT'S VITALS INCLUDING OXYGEN SATURATION GRADUALLY IMPROVED. ON (B)(6) 2024, DUE TO LOW BLOOD PRESSURE (97/61MMHG), TERAMURO WAS SUSPENDED AGAIN, AND SUPPLEMENTAL OXYGEN THERAPY WAS DISCONTINUED ON (B)(6) 2024. ON (B)(6) 2024, THE EVENT WAS RESOLVED, AND SUBJECT WAS DISCHARGED FROM HOSPITAL. AS PER THE PHYSICIAN, THE POSSIBLE CAUSE OF THE EVENT IS SUBJECT'S OBESITY (THICK FAT AND TOUGH SKIN), WHICH CAUSED THE GUIDEWIRE TO BE WITHDRAWN WHEN THE SHEATH WAS INSERTED, CAUSING THE TIP OF THE DILATOR TO DAMAGE THE BLOOD VESSEL LEADING TO PSEUDOANEURYSM. ALSO, PER THE PHYSICIAN, THE CAUSE OF BLEEDING INTO RETROPERITONEUM WAS PROBABLY DUE TO RUPTURED PSEUDOANEURYSM CAUSED BY ABDOMINAL PRESSURE AFTER AMBULATION ON POST PROCEDURE DAY 1 WHICH LED TO DECRESED IN BP.

    Description of Event or Problem · 0

    THERE IS NO INDICATION OF ANY FAILURE OF THE DEVICE. IN ADDITION THERE IS NO INDICATION OF ANY MISUSE OF THE DEVICE. EVENT: VASCULAR PSEUDOANEURYSM. 61-YEAR-OLD FEMALE ENROLLED IN RADIANCE DUO ON (B)(6) 2024. PAST MEDICAL HISTORY WAS SIGNIFICANT FOR CONSTIPATION, THYROID TUMOR AND COXARTHROSIS. SUBJECT WAS ON TWO ANTIHYPERTENSIVE MEDICATIONS AT THE TIME OF CONSENT. ON (B)(6) 2024, THE SUBJECT UNDERWENT RENAL DENERVATION PROCEDURE, AND THE PROCEDURE WAS UNEVENTFUL. POST PROCEDURE SUBJECT WAS STABLE WITH NORMAL VITAL SIGNS. ON (B)(6) 2024, 1 DAY POST-PROCEDURE, SUBJECT'S PRE-AMBULATION BP WAS FOUND 112/67 MMHG WHICH REDUCED TO 96/55 MMHG AFTER AMBULATION. THE SUBJECT COMPLAINED OF RIGHT LOWER ABDOMINAL PAIN AND COLD SWEATS. SUBJECT'S BLOOD PRESSURE FURTHER DROPPED TO 72/38 MMHG, HR: 95 BPM WITHIN THE NEXT 3 HOURS. ON EXAMINATION, THE SUBJECT APPEARED PALE WITH PALPEBRAL CONJUNCTIVAL ANEMIA AND HAD IMPAIRED CONSCIOUSNESS HOWEVER, NO SIGNS OF VISIBLE BLEEDING OR HEMATOMA AT THE PUNCTURE SITE WERE NOTED. SOLULACT INFUSION AND VASOPRESSORS WERE INITIATED TO MAINTAIN BLOOD PRESSURE. A CONTRAST CT SCAN WAS PERFORMED, WHICH NOTED INJURY TO THE RIGHT EXTERNAL ILIAC ARTERY AND PSEUDOANEURYSM. THE SUBJECT'S BP REMAINED LOW 78/43 MMHG, HR: 82 BPM AFTER 1 HOUR. CONSEQUENTLY, AN EMERGENCY INTERVENTIONAL RADIOLOGY PROCEDURE WAS PERFORMED. SUBJECT WAS TREATED WITH VIABAHN STENT (8.0MM/ 50MM) IMPLANTATION IN INJURED PART OF RIGHT EXTERNAL ILIAC ARTERY. THE SUBJECT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. WHILE IN ICU, SUBJECTS ANEMIA PROGRESSED WITH HB DROPPING TO 8.6G/DL, CONSEQUENTLY BLOOD TRANSFUSION WAS INITIATED. ON (B)(6) 2024, THE ANTIHYPERTENSIVE DRUG: TERAMURO (TELMISARTAN AND AMLODIPINE BESILATE) WAS SUSPENDED. THE SUBJECT'S SYSTOLIC BP INCREASED TO 110-140 MMHG, HR: 90 BPM. ON (B)(6) 2024, A CONTRAST CT SCAN WAS PERFORMED TO MONITOR HEMOSTASIS AFTER TREATING THE PSEUDOANEURYSM, WHICH NOTED A RETROPERITONEAL HEMATOMA. ON (B)(6) 2024, THE SUBJECT WAS TRANSFERRED FROM ICU TO GENERAL WARD. SUBJECT'S CONDITION IMPROVED. THE EVENT IS ONGOING. AS PER THE PHYSICIAN, THE POSSIBLE CAUSE OF THE EVENT IS SUBJECT'S OBESITY (THICK FAT AND TOUGH SKIN), WHICH CAUSED THE GUIDEWIRE TO BE WITHDRAWN WHEN THE SHEATH WAS INSERTED, CAUSING THE TIP OF THE DILATOR TO DAMAGE THE BLOOD VESSEL LEADING TO PSEUDOANEURYSM. ALSO PER THE PHYSICIAN, THE CAUSE OF BLEEDING INTO RETROPERITONEUM WAS PROBABLY DUE TO RUPTURED PSEUDOANEURYSM CAUSED BY ABDOMINAL PRESSURE AFTER AMBULATION ON POST PROCEDURE DAY 1 WHICH LED TO DECREASED IN BP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880518 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Life Threatening AZOSEMIDE.| BLOOD TRANSFUSION.| BLOOD TRANSFUSION.| OXYGEN SUPPLEMENTATION.| SOLULACT INFUSION.| SOLULACT INFUSION.| TOLVAPTAN.| VASOPRESSOR.| VASOPRESSOR.