BEUDAMED
    FDA Adverse Event Death Summary report: N

    CVAC ASPIRATION SYSTEM

    MDR report key: 20626848 · Received November 7, 2024

    Report

    Report Number
    3014683069-2024-00001
    Event Type
    Death
    Date Received
    November 7, 2024
    Date of Event
    October 4, 2024
    Report Date
    November 6, 2024
    Manufacturer
    CALYXO, INC.
    Product Code
    FED
    PMA / PMN Number
    K233472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF (B)(6) 2024 THERE HAVE BEEN OVER (B)(4) SURE PROCEDURES PERFORMED WITH THE FIRST GENERATION AND SECOND GENERATION CVAC SYSTEMS; APPROXIMATELY (B)(4) OF THOSE PROCEDURES WERE PERFORMED WITH THE SECOND-GENERATION SYSTEM. TO DATE THERE WAS ONE SEVERE ADVERSE EVENT REPORTED (DEATH) IN A CRITICALLY ILL PATIENT, AS DESCRIBED IN THIS REPORT. THIS MORTALITY RATE IS IN LINE WITH THE COMPLICATION RATE REPORTED FOR STANDARD URETEROSCOPY WITHOUT SUCTION BY SOMANI ET AL IN A STUDY OF (B)(4) PATIENTS (SOMANI ET AL. 2017). SOMANI BK, GUISTI G, SUN Y, OSTHER PJ, FRANK M, DE SIO M, TURNA B, AND DE LA ROSETTE J. 2017. COMPLICATIONS ASSOCIATED WITH URETERORENOSCOPY (URS) RELATED TO TREATMENT OF UROLITHIASIS: THE CLINICAL RESEARCH OFFICE OF ENDOUROLOGICAL SOCIETY URS GLOBAL STUDY. WORLD J UROL. 35(5):675-681.

    Additional Manufacturer Narrative · 0

    CORRECTION A2: PATIENT AGE WAS UPDATED. CORRECTION B5: UPDATED INFORMATION RELATED TO THE EVENT. CORRECTION E4: CHANGED TO YES AS HOSPITAL FILED A MEDSUN REPORT. (UF# (B)(4)). A REVIEW OF THE LOT HISTORY RECORD FOR LOT# P02084 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A MORBIDLY OBESE PATIENT WITH SUSPECTED SEPSIS AND SIGNIFICANT CO-MORBIDITIES (PRIOR HISTORY OF URINARY TRACT AND KIDNEY INFECTIONS, LYMPHEDEMA, ANEMIA), WHO HAD UNDERGONE A PREVIOUS RIGHT PCNL UNDERWENT A RIGHT SIDE URETEROSCOPY STONE REMOVAL PROCEDURE. INITIAL INSPECTION OF THE COLLECTING SYSTEM REVEALED DEBRIS, BLOOD CLOTS, AND VISCOUS FLUID IN ADDITION TO KIDNEY STONES. THE CVAC SYSTEM WAS USED TO CLEAR BLOOD CLOTS AND DEBRIS PRIOR TO INITIATING LASER LITHOTRIPSY. LASER LITHOTRIPSY AND STONE REMOVAL WAS THEN PERFORMED WITH THE CVAC SYSTEM AND UNKNOWN LASER FIBER. AN UNKNOWN STONE RETRIEVAL BASKET WAS ALSO USED FOR STONE FRAGMENT REMOVAL. THE MAJORITY OF THE PROCEDURE WAS CONDUCTED IN THE UPPER POLE. APPROXIMATELY 2 CM OF STONE BURDEN WAS REMOVED FROM THE KIDNEY, WITH PROCEDURAL DIFFICULTY CAUSED BY THE VISIBILITY CHALLENGES DUE TO HIGH VISCOSITY FLUID AND DEBRIS THAT MAY HAVE REDUCED IRRIGANT FLOW. THE CVAC SYSTEM WAS REMOVED FROM THE PATIENT BETWEEN 5 AND 7 TIMES DURING THE PROCEDURE TO CHECK FOR CLOGGING, AND NO CLOGS OR OTHER DEVICE ISSUES WERE OBSERVED. AT THE END OF THE PROCEDURE, THE CVAC ASPIRATION SYSTEM AND OTHER ACCESSORIES WERE REMOVED WITHOUT INCIDENT AND AN UNKNOWN URETERAL STENT WAS PLACED ON THE RIGHT SIDE. A URETERAL STENT WAS THEN INSERTED ON THE PATIENT'S LEFT SIDE. A FOLEY CATHETER WAS INSERTED AND THE PROCEDURE WAS CONCLUDED. THE ANESTHESIOLOGIST NOTED A DECREASE IN BLOOD PRESSURE. WHILE IN RECOVERY THE PATIENT EXPERIENCED FLANK PAIN, A HYPOTENSIVE EPISODE, AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). ULTRASOUND REVEALED FLUID AROUND THE KIDNEY AND A BLEEDING CONCERN. AS REPORTED, THE PATIENT DEVELOPED HEMORRHAGIC SHOCK, SEPTIC PHYSIOLOGY, AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). THE PATIENT WAS TRANSFERRED TO AN OPERATING ROOM AND INTERVENTIONAL RADIOLOGY ATTEMPTED RENAL ARTERY EMBOLIZATION. THE PATIENT CONDITION WORSENED. AN EXPLORATORY LAPAROTOMY WITH NEPHRECTOMY WAS INITIATED AND A WOUND WAS OBSERVED IN THE UPPER POLE OF THE RIGHT KIDNEY. THE PATIENT RECEIVED 15 UNITS OF BLOOD; HOWEVER, THE PATIENT CODED AND EFFORTS TO RESUSCITATE THE PATIENT WERE UNSUCCESSFUL.

    Description of Event or Problem · 0

    ON (B)(6)2024, A MORBIDLY OBESE PATIENT WITH SUSPECTED SEPSIS AND SIGNIFICANT CO-MORBIDITIES (PRIOR HISTORY OF URINARY TRACT AND KIDNEY INFECTIONS, LYMPHEDEMA, ANEMIA), WHO HAD UNDERGONE A PREVIOUS RIGHT PCNL UNDERWENT A RIGHT SIDE URETEROSCOPY STONE REMOVAL PROCEDURE. INITIAL INSPECTION OF THE COLLECTING SYSTEM REVEALED DEBRIS, BLOOD CLOTS, AND VISCOUS FLUID IN ADDITION TO KIDNEY STONES. THE CVAC SYSTEM WAS USED TO CLEAR BLOOD CLOTS AND DEBRIS PRIOR TO INITIATING LASER LITHOTRIPSY. LASER LITHOTRIPSY AND STONE REMOVAL WAS THEN PERFORMED WITH THE CVAC SYSTEM AND UNKNOWN LASER FIBER. AN UNKNOWN STONE RETRIEVAL BASKET WAS ALSO USED FOR STONE FRAGMENT REMOVAL. THE MAJORITY OF THE PROCEDURE WAS CONDUCTED IN THE RIGHT KIDNEY UPPER POLE. APPROXIMATELY 2 CM OF STONE BURDEN WAS REMOVED FROM THE KIDNEY, WITH INITIAL PROCEDURAL DIFFICULTY CAUSED BY VISIBILITY CHALLENGES DUE TO CLOUDY URINE, INFLAMMATORY DEBRIS, AND A BLOOD CLOT FROM A PREVIOUS PCNL PROCEDURE (LOWER POLE), THAT MAY HAVE REDUCED IRRIGANT OUTFLOW RATE FROM THE KIDNEY. THE CVAC SYSTEM WAS REMOVED FROM THE PATIENT BETWEEN 5 AND 7 TIMES DURING THE PROCEDURE TO CHECK FOR CLOGGING, AND NO CLOGS OR OTHER DEVICE ISSUES WERE OBSERVED OR REPORTED. AT THE END OF THE PROCEDURE, THE CVAC ASPIRATION SYSTEM AND OTHER ACCESSORIES WERE REMOVED WITHOUT INCIDENT AND AN UNKNOWN URETERAL STENT WAS PLACED ON THE RIGHT SIDE. A URETERAL STENT WAS THEN INSERTED ON THE PATIENT'S LEFT SIDE. A FOLEY CATHETER WAS INSERTED AND THE PROCEDURE WAS CONCLUDED. THE ANESTHESIOLOGIST NOTED A DECREASE IN BLOOD PRESSURE. WHILE IN RECOVERY THE PATIENT EXPERIENCED FLANK PAIN, A HYPOTENSIVE EPISODE, HEMATURIA AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). ULTRASOUND REVEALED FLUID AROUND THE KIDNEY AND A BLEEDING CONCERN. AS REPORTED, THE PATIENT DEVELOPED HEMORRHAGIC SHOCK AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). IN ADDITION, THERE WAS CONCERN FOR UROSEPSIS. THE PATIENT WAS TRANSFERRED TO AN OPERATING ROOM AND INTERVENTIONAL RADIOLOGY ATTEMPTED RENAL ARTERY EMBOLIZATION. THE PATIENT'S CONDITION WORSENED. AN EXPLORATORY LAPAROTOMY WITH NEPHRECTOMY WAS INITIATED AND A WOUND WAS OBSERVED IN THE UPPER POLE OF THE RIGHT KIDNEY. THE PATIENT RECEIVED 15 UNITS OF BLOOD; HOWEVER, THE PATIENT DEVELOPED CARDIOVASCULAR ARREST AND EFFORTS TO RESUSCITATE THE PATIENT WERE UNSUCCESSFUL. ON 02-DEC-2024 ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL THAT ACCORDING TO A REVIEW OF THE PHYSICIAN'S DOCUMENTATION IN THIS PATIENT'S MEDICAL RECORD, THE CAUSE OF DEATH WAS HEMORRHAGIC SHOCK AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). THERE WAS NO POST-MORTEM EXAMINATION PERFORMED. ON (B)(6)2024 FDA NOTIFIED CALYXO INC. OF THE HOSPITAL'S MEDSUN REPORT (UF# (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997883 CVAC ASPIRATION SYSTEM CVAC ASPIRATION SYSTEM FED CALYXO, INC. CVC127020-1 P02084

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Death| R BARD URETERAL ACCESS SHEATH| LASER| NEPTUNE SURGICAL SUCTION CONSOLE| SAFETY WIRE| STENTS| STONE RETRIEVAL BASKET