Edison EDNTC1001 (UDI 00850006962006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00850006962006), received between Feb 21, 2025 and Sep 21, 2026 — classified as 6 deaths, 23 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Chills; Fatigue; Fever; Low White Blood Cell Count; Necrosis

  MAUDE report 50847383 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  As part of the BOOMBOX post-market clinical study, on (b)(6) 2025, a 77 year old female patient with a history of hepatocellular carcinoma received histotripsy treatment to two lesions in liver segments VI and VII for a total planned treatment volume (PTV) of approximately 43.4 cc. As per treating facility standard of care, the patient was held overnight for observation and discharged the following day. Later that day, the patient developed red-tinged sputum with clots. The patient contacted the treating physician and was advised to present to an emergency department for evaluation. On (b)(6) the patient was admitted to a local hospital with presumptive pneumonia and acute kidney injury although creatinine values were not available (baseline or elevated). The patient remained hospitalized until transfer to the treating facility was initiated on (b)(6). The patient was evaluated by the treating physician on (b)(6). After review of the outside hospital records and imaging, the treating physician documented that the patient did not appear to have pneumonia and that the pulmonary findings were more likely atelectasis related to single-lung ventilation during the histotripsy procedure.

  Patient problems: Renal Impairment

  MAUDE report 50184463 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  HISTOSONICS WAS MADE AWARE OF AN ABSTRACT FOR AN UPCOMING SOCIETY FOR INTERVENTIONAL RADIOLOGY ANNUAL SCIENTIFIC MEETING THAT WILL BE HELD BETWEEN (B)(6) 2026 - (B)(6) 2026. THE ABSTRACT WILL BE PRESENTED AS PART OF SIR 2026 TRADITIONAL POSTER PRESENTATIONS (BREUER ET AL. LONGER-TERM OUTCOMES POST HISTOTRIPSY OF LIVER TUMORS: LESSONS LEARNED AND NEXT STEPS) AND REPORTED ONE PATIENT WAS RE-HOSPITALIZED FOR SEPSIS RELATED TO TREATMENT. ONE PATIENT EXPERIENCED HEPATIC VEIN THROMBUS IMMEDIATELY POST-PROCEDURE, THOUGH THE ABSTRACT DID NOT DETAIL IF MEDICAL INTERVENTION WAS REQUIRED TO ADDRESS THE THROMBUS.

  Patient problems: Sepsis; Thrombosis/Thrombus

  MAUDE report 24327162 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  HISTOSONICS WAS MADE AWARE OF AN ABSTRACT AT THE HEP-DART CONFERENCE (HASSANEIN, R. T., HEFNER, A. M., OLIVER, D., BANUELOS, M., BARAKAT, F., & HASSANEIN, T. I. (2025). HISTOTRIPSY, A NOVEL NON-INVASIVE THERAPY FOR LIVER TUMORS: AN OUTPATIENT MEDICAL MANAGEMENT EXPERIENCE. SOUTHERN CALIFORNIA ABDOMINAL CANCER GROUP; SOUTHERN CALIFORNIA TRANSPLANTATION INSTITUTE RESEARCH FOUNDATION; SOUTHERN CALIFORNIA LIVER CENTERS) IN WHICH TWO PATIENTS HAD POST-TREATMENT ACUTE RENAL INJURY INDICATED BY ELEVATED CREATININE. PER THE ABSTRACT, THE EVENTS RESOLVED IN 3-7 DAYS WITH HYDRATION AND SUPPORTIVE CARE.

  Patient problems: Renal Impairment

  MAUDE report 24028421 ↗
• DeathDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 57 YEAR OLD MALE WITH EXTENSIVE TUMOR BURDEN (APPROXIMATELY 50% OF LIVER VOLUME) AND A HISTORY OF ACINAR PANCREATIC CANCER WITH METASTASIS TO THE LIVER RECEIVED THREE OVERLAPPING HISTOTRIPSY TREATMENTS TO A LARGE LIVER TUMOR INVOLVING SEGMENT 5 AND A SINGLE TREATMENT TO LIVER SEGMENT 3, FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 127.34CC. PER THE TREATING PHYSICIAN, THE PATIENT HAD PRIOR EXTERNAL BEAM RADIATION THERAPY AND Y90, WHICH OVERLAPPED WITH THE HISTOTRIPSY TREATMENT. TWO MONTHS PRIOR, THE PATIENT HAD HISTOTRIPSY TO THREE TUMORS AND TOLERATED THE TREATMENT WELL. DURING THE THIRD HISTOTRIPSY SESSION, THE FOLEY CATHETER OUTPUT APPEARED BLOODY, AND THE PATIENT BECAME HYPOTENSIVE. THE ANESTHESIA TEAM INTERVENED AND INITIALLY APPROVED CONTINUATION OF THE PROCEDURE; HOWEVER, TREATMENT WAS PAUSED AGAIN WHEN THE URINE COLOR CHANGED SIGNIFICANTLY. THE CASE WAS ABORTED AFTER THE FOURTH TREATMENT TO SEGMENT 3. IV FLUIDS WERE STARTED AT THE END OF THE PROCEDURE. IN THE RECOVERY ROOM, THE PATIENT EXPERIENCED ABDOMINAL DISCOMFORT AND PAIN, AND IV PAIN MEDICATION WAS ADMINISTERED. THE TREATING PHYSICIAN NOTIFIED THE ON-CALL TEAM ABOUT THE CASE AND WAS LATER INFORMED T

  Patient problems: Abdominal Pain; Hematuria; Intra-Abdominal Hemorrhage; Low Blood Pressure/ Hypotension

  MAUDE report 23802548 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HISTOSONICS WAS MADE AWARE OF A JOURNAL ARTICLE PUBLISHED WITHIN THE INTERNATIONAL JOURNAL OF SURGERY, (CHAN, ALBERT CY ET AL. "PROSPECTIVE ANALYSIS ON THE OUTCOMES OF HISTOTRIPSY FOR PRIMARY AND METASTATIC LIVER TUMOURS.", 10 NOV. 2025, DOI:10.1097/JS9.0000000000003856), WHICH IDENTIFIED A PREVIOUSLY UNREPORTED PATIENT RE-ADMISSION DUE TO FEVER THAT WAS RESOLVED AFTER PARACETAMOL MEDICATION.

  Patient problems: Fever

  MAUDE report 23789129 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF ONGOING SEQUALAE RELATIVE TO HISTOTRIPSY TREATMENT, THE PATIENT DEVELOPED A BILE LEAK AND SUBSEQUENTLY REQUIRED BILIARY STENT PLACEMENT FOR MANAGEMENT AS WELL AS HOSPITALIZATION.

  Patient problems: Biliary Leak; Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm; Renal Impairment

  MAUDE report 23707693 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, AN 80-YEAR-OLD FEMALE PATIENT WITH COLORECTAL CANCER, RECEIVED TWO OVERLAPPING HISTOTRIPSY TREATMENTS TO A SINGLE 5-6 CM DIAMETER LESION IN LIVER SEGMENT 7/8 FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 62.8 CC. AT THE TIME OF THE HISTOTRIPSY PROCEDURE, THE PATIENT WAS RECEIVING FOLFIRI AND AVASTIN FOR THEIR SYSTEMIC DISEASE. PER THE TREATING PHYSICIAN, THE PTV WAS LOCATED HIGH IN THE DOME OF THE LIVER, NEAR THE LUNG BASE, WITH RIB OBSTRUCTION IN THE ACOUSTIC PATHWAY. THE PHYSICIAN DELIVERED TWO OVERLAPPING TREATMENTS IN THE LEFT LATERAL DECUBITUS POSITION WITH SOME OVERLAP OF THE ACOUSTIC PATHWAY. FOLLOWING PLANNING PULSES AND AT THE REVIEW TREATMENT PARAMETERS SCREEN (INCLUDING TREATMENT TIME), THE PHYSICIAN ELECTED TO MODIFY/ADJUST THE TREATMENT PARAMETERS, INCLUDING THE DEPTH (E.G., MARK DISTANCE FROM THE BODY WALL TO TARGET), TO SHORTEN THE PROCEDURE TIME, SO THAT EACH HISTOTRIPSY TREATMENT OF THE PRESCRIBED PTV WAS APPROXIMATELY 50% SHORTER IN TIME. POST-PROCEDURE, SOME SKIN REDNESS WITH BLISTERING OR "BURN" WAS OBSERVED. THE PATIENT WAS TREATED WITH OTC CREAM AND WOUND DRESSING. POST-PROCEDURE CT IMAGING LATER THAT DAY SHOWED TREATMENT CHANGES AT THE LOCATIO

  Patient problems: Erythema; Full thickness (Third Degree) Burn; Pain; Pleural Effusion; Swelling/ Edema

  MAUDE report 23550298 ↗
• DeathNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF THE BOOMBOX POST-MARKET CLINICAL TRIAL, AN 85 YEAR OLD FEMALE PATIENT WITH A DIAGNOSIS OF COLORECTAL CANCER WITH METASTASES TO THE LIVER HAD HISTOTRIPSY ON (B)(6) 2025 TO A 4 CM LESION IN LIVER SEGMENT 5 FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 20.9 CC. THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENTS' DAUGHTER REPORTED THAT THE PATIENT WAS VERY GROGGY FROM ANESTHESIA, SLEEPING MORE THAN NORMAL AND HAD LOW BLOOD PRESSURE. THE FOLLOWING DAY, THE PATIENT WAS FOUND UNRESPONSIVE AND WAS UNABLE TO BE REVIVED. HISTOSONICS WAS MADE AWARE OF THE EVENT ON OCTOBER 9,2025. NO ADDITIONAL CASE INFORMATION WAS AVAILABLE. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS WERE ALLEGED TO HAVE OCCURRED DURING THE PROCEDURE.

  Patient problems: Insufficient Information; Low Blood Pressure/ Hypotension; Sleepiness/Drowsiness/Somnolence

  MAUDE report 23501150 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 65-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEPATOCELLULAR CHOLANGIOCARCINOMA RECEIVED TWO HISTOTRIPSY TREATMENTS TO LIVER SEGMENTS 4 AND 5, FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 39.1 CC. A BLEED WAS IDENTIFIED DURING IMMEDIATE POST IMAGING VIA CT. THE PATIENT WAS MOVED TO ANOTHER OPERATING ROOM TO EMBOLIZE THE BLEED. HER PLATELET COUNT DROPPED BELOW 50 NECESSITATING TRANSFUSION. PATIENT IS DOING WELL POST-PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23383538 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 72-YEAR-OLD FEMALE WITH A HISTORY OF BREAST CANCER METASTASIS TO THE LIVER RECEIVED HISTOTRIPSY TREATMENT TO A SINGLE LESION LOCATED IN LIVER SEGMENT I FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 9 CC. THE PROCEDURE INCLUDED THREE CYCLES THROUGH THE IN-VIVO CALIBRATION PORTION OF THE WORKFLOW, DUE TO TREATMENT PARAMETERS EXCEEDING THERMAL SAFEGUARDS. THE TREATING PHYSICIAN ADMINISTERED 3,000 UNITS OF HEPARIN ON TWO SEPARATE OCCASIONS DURING THE HISTOTRIPSY PROCEDURE DUE TO THE PROXIMITY OF THE TARGETED TUMOR TO THE HEPATIC VASCULATURE. INTRAVENOUS FLUIDS WERE ADMINISTERED THROUGHOUT THE PROCEDURE, AND URINE OUTPUT WAS CONTINUOUSLY MONITORED. THE POST-PROCEDURE CT DEMONSTRATED A PORTAL VEIN THROMBOSIS AND A POTENTIAL BLEED AT THE TREATMENT SITE WITH AN ASSOCIATED HEMOGLOBIN DROP OF 2 G/DL. THE PATIENT REMAINED IN THE HOSPITAL FOR TWO DAYS. IN ADDITION, THE PATIENT WAS STARTED ON LOW-MOLECULAR WEIGHT HEPARIN WHILE IN THE HOSPITAL AND DISCHARGED ON ELIQUIS FOR THE PORTAL VEIN THROMBUS. AT THE ONE-MONTH FOLLOW-UP, IMAGING REVEALED RESIDUAL BUT IMPROVING PORTAL VEIN THROMBOSIS, AND PERFUSION ABNORMALITIES INVOLVING THE LEFT HEPATIC LOBE AND SEGMENT III.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23324190 ↗
• InjuryOct 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 73 YEAR OLD FEMALE PATIENT WITH A HISTORY OF NEUROENDOCRINE TUMORS WITH METASTASIS TO THE LIVER WAS TREATED WITH HISTOTRIPSY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND INCLUDED TREATMENT TO TWO LESIONS (SEGMENTS IV AND VI) AND WAS COMPRISED OF THREE HISTOTRIPSY PLANNED TREATMENT VOLUMES (PTVS) FOR A TOTAL DELIVERED TREATMENT VOLUME OF APPROXIMATELY 69CC. AS A NOTE, TWO OF THE PTVS INCLUDED PARTIALLY OVERLAPPING TREATMENTS TO ENABLE COVERAGE ON A LARGER LESION (E.G., ESTIMATED 55CC OF LESION/LIVER TISSUE TREATED BASED ON OVER-LAP). CONTRAST ENHANCED ULTRASOUND (CEUS) AND CEUS MICROBUBBLE CONTRAST AGENT WAS UTILIZED DURING THE PLANNING STAGE OF THE WORKFLOW AND PRIOR TO THERAPY EMISSION. POST-CONTRAST ENHANCED ULTRASOUND SHOWED POSSIBLE RESIDUAL FLOW WITHIN THE TREATED VOLUME ON COLOR DOPPLER, INDICATIVE OF PATENT VESSELS IN THE HISTOTRIPSY TREATMENT VOLUME. POST-PROCEDURE, THE PATIENT DEVELOPED OLIGURIA/ANURIA, RISING CREATININE, AND SIGNIFICANT PAIN AND WAS ULTIMATELY ADMITTED TO ICU ON THE DAY OF THE PROCEDURE. CONTRAST-ENHANCED CT WAS PERFORMED DUE TO CONCERN FOR BLEEDING. NO EVIDENCE OF VASCULITIS OR VASCULOPATHY AND THE VESSELS APPEARED NORMAL ON IMAGING. T

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Pain; Pseudoaneurysm; Renal Impairment

  MAUDE report 23272921 ↗
• DeathSep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HISTOSONICS WAS MADE AWARE OF A MANUSCRIPT PENDING PUBLICATION WHICH IDENTIFIED A PREVIOUSLY UNREPORTED PATIENT DEATH WHICH OCCURRED ONE-WEEK POST-HISTOTRIPSY PROCEDURE DUE TO RESPIRATORY DISTRESS OF UNKNOWN ETIOLOGY.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 23100475 ↗
• DeathSep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 73-YEAR-OLD MALE WITH A HISTORY OF CARDIOVASCULAR DISEASE AND COLORECTAL CANCER WITH METASTASIS TO THE LIVER RECEIVED A SECOND HISTOTRIPSY TREATMENT ON (B)(6) 2025 (PREVIOUS TREATMENT WAS 1 YEAR PRIOR) TO A SINGLE SEGMENT 6 LIVER TUMOR FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 18.7 CC. FOLLOWING THE PROCEDURE, THE PATIENT WAS STABLE WITHOUT ANY CLINICAL COMPLICATIONS AND WENT HOME. THE NEXT MORNING THE FAMILY FOUND THE PATIENT IN HIS BED WHERE HE HAD PASSED AWAY. NO AUTOPSY WAS PERFORMED SO THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038747 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 65-YEAR-OLD FEMALE WITH METASTATIC COLON ADENOCARCINOMA TO THE LIVER WAS ENROLLED IN THE POST-MARKET CLINICAL TRIAL, BOOOMBOX AND HAD HISTOTRIPSY TO ONE LESION IN LIVER SEGMENT 4B (TOTAL PLANNED TREATMENT VOLUME (PTV) OF ~57 CC) ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS REFERRED TO THE EMERGENCY DEPARTMENT AFTER A THREE-WEEK HISTORY OF FEVER, CHILLS, FATIGUE, AND NEUTROPENIA. ON ADMISSION, HER WHITE BLOOD COUNT WAS 2.67 K/L AND ANC (ABSOLUTE NEUTROPHIL COUNT) WAS ~800, WHICH IMPROVED TO 1,300 BY (B)(6) AS HER FEVER RESOLVED CLINICALLY. AN ABDOMINAL MRI ON (B)(6) SHOWED TWO KNOWN HEPATIC METASTASES AND A NEW 6.1 × 3.7 CM PERIPHERALLY ENHANCING, CENTRALLY NECROTIC LESION AT THE SEGMENT IV/V JUNCTION; ALTHOUGH A DIAGNOSIS OF NECROTIC METASTASIS WAS FAVORED, SUPERIMPOSED INFECTION COULD NOT BE EXCLUDED AND WAS TREATED ACCORDING TO STANDARD SITE CLINICAL PRACTICE. BLOOD CULTURES REMAINED NEGATIVE.

  Patient problems: Chills; Fatigue; Fever; Low White Blood Cell Count

  MAUDE report 22980915 ↗
• DeathAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 79-YEAR-OLD FEMALE PATIENT WITH METASTATIC GALLBLADDER CANCER UNDERWENT HISTOTRIPSY TO THREE HEPATIC METASTASES ACROSS FOUR TREATMENT TARGETS IN THE RIGHT LIVER FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 96.38 CC. PAST MEDICAL HISTORY INCLUDED CHOLECYSTECTOMY, PULMONARY HYPERTENSION, PREMATURE VENTRICULAR CONTRACTIONS, AND VENOUS THROMBOEMBOLISM (ON LONG-TERM XARELTO). THE ANESTHESIOLOGIST ASSESSED THE PATIENT AS MODERATE RISK. THE PROCEDURE ITSELF WAS UNEVENTFUL APART FROM TRANSIENT HYPOTENSION AND OLIGURIA. BY POST-OPERATIVE DAY (POD) 1, OLIGURIA PERSISTED AND NEPHROLOGY NOTED HEMATURIA AND PROTEINURIA. ON POD2, LEUKOCYTOSIS DEVELOPED, BLOOD CULTURES WERE OBTAINED, AND CREATININE ROSE WHICH INDICATED ACUTE KIDNEY INJURY. DURING THIS PERIOD, THE PATIENT FELL AND WAS FOUND TO BE HYPOTENSION AND MINOR HEAD TRAUMA (HEAD CT NORMAL). A CHEST/ABDOMEN/PELVIS (NON-CONTRAST) CT REVEALED ASPIRATION PNEUMONIA, RIGHT PNEUMOTHORAX, PULMONARY HYPERTENSION, PNEUMOBILIA, INTRAHEPATIC GAS, AND A NECROTIC HEPATIC COLLECTION, ALONG WITH EXTENSIVE HEPATIC AND OSSEOUS METASTASES. BY POD3, BLOOD CULTURES GREW STREPTOCOCCUS AGALACTIAE (GROUP B) AND ESCHERICHIA COLI. ON POD4, THE PAT

  Patient problems: Aspiration Pneumonitis; Aspiration/Inhalation; Head Injury; Hematuria; High White Blood Cell Count; Kidney injury; Low Blood Pressure/ Hypotension; Necrosis; Pneumonia; Urinary Retention

  MAUDE report 22913647 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RECENT ABSTRACT SUBMISSION TITLED "EARLY EXPERIENCE OF HISTOTRIPSY IN A MULTIDISCIPLINARY LIVER CANCER PROGRAM" FOR THE WORLD TRANSPLANT CONGRESS (WTC) MEETING HELD ON (B)(6) 2025 INDICATED THAT A PATIENT HAD A BILOMA/BILIARY STRICTURE WHICH REQUIRED ENDOSCOPIC AND PERCUTANEOUS BILIARY INTERVENTION. NO ADDITIONAL DETAILS WERE PROVIDED IN THE ABSTRACT, AND DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION, NONE HAS BEEN RECEIVED. NO RELATED DEVICE MALFUNCTION WAS IDENTIFIED IN THE ABSTRACT.

  Patient problems: Biliary Leak

  MAUDE report 22874493 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 74-YEAR-OLD FEMALE WITH A HISTORY OF COLORECTAL CANCER METASTATIC TO THE LIVER UNDERWENT HISTOTRIPSY TREATMENT ON (B)(6) 2025, TARGETING SEGMENT IV. FOUR OVERLAPPING LESIONS WERE TREATED WITH A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 111 CC. THE PROCEDURE WAS COMPLETED WITHOUT DEVICE MALFUNCTION OR INTRA-PROCEDURAL COMPLICATIONS. THE HISTOTRIPSY TREATMENT INCLUDED AN AREA ABUTTING THE GALLBLADDER, WITH PORTIONS OF THE GALLBLADDER ENCOMPASSED WITHIN THE PTV. THE TREATING PHYSICIAN PROCEEDED WITH FULL AWARENESS OF THE POTENTIAL RISK OF HEMORRHAGE ASSOCIATED WITH GALLBLADDER INVOLVEMENT, WHICH WAS OBSERVED IN THE CT IMMEDIATELY POST PROCEDURE. HEMOGLOBIN REMAINED STABLE AND THE PATIENT EXHIBITED NO SIGNS OR SYMPTOMS OF CHOLECYSTITIS UNTIL (B)(6) WHICH WAS MANAGED BY PLACEMENT OF A PERCUTANEOUS CHOLECYSTOSTOMY TUBE ON (B)(6). AT THE TIME OF TREATMENT, THE PATIENT WAS ACTIVELY RECEIVING CAPECITABINE, OXALIPLATIN, AND BEVACIZUMAB, WITH NO TREATMENT HOLIDAY. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED ACUTE KIDNEY INJURY (AKI), WITH CREATININE RISING TO 2.85 MG/DL AND EGFR DECLINING TO (B)(6). SHE REMAINED ANURIC AND REQUIRED INITIATION OF DIALYSIS ON THE SAME DAY. AS OF (B)(6), SHE

  Patient problems: Gastrointestinal Hemorrhage; Renal Impairment

  MAUDE report 22371455 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 70-YEAR-OLD MALE PATIENT WITH A HISTORY OF STAGE IV SQUAMOUS CELL CARCINOMA OF THE TONGUE WITH LUNG AND LIVER METASTASES RECEIVED HISTOTRIPSY TREATMENT ON (B)(6) 2025 AS PART OF THE BOOMBOX STUDY. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE PROCEDURE. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO HOSPITAL FOR HEMOPTYSIS AND DURING HOSPITALIZATION EXPERIENCED CHEST PAIN THE FOLLOWING DAY. PATIENT HAS A CLINICAL HISTORY OF CORONARY ARTERY DISEASE AND RECEIVED CORONARY ARTERY BYPASS GRAFT IN 2003. ON (B)(6), THE PATIENT HAD 2/4 PATENT GRAFTS AND RECEIVED A NEW OCCLUDED SAPHENOUS VEIN GRAFT TO RIGHT CORONARY ARTERY GRAFT. TREATMENT INCLUDED: HEPARIN AND DUAL ANTIPLATELET THERAPY WITH ASPIRIN AND PLAVIX. NO ADDITIONAL INTERVENTION WAS REQUIRED. ON (B)(6), HIGH-SENSITIVITY TROPONIN I (TNIH) WAS 3,790 WHICH INDICATED A CARDIAC EVENT HAD OCCURRED. THE PATIENT WAS DISCHARGED ON (B)(6) AND THE PATIENT WAS DIRECTED TO FOLLOW UP AS OUTPATIENT. DUE TO THE FACT THAT THE HISTOTRIPSY TREATMENT WAS ON (B)(6) AND THE CHEST PAIN WAS A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WHICH OCCURRED ON (B)(6) (10 DAYS LATER), THE INVESTIGATOR DETERMINED IT COULD POSSIBLY RELATE

  Patient problems: Angina; Hemoptysis; Myocardial Infarction

  MAUDE report 22204498 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 87-YEAR-OLD FEMALE WITH CHOLANGIOCARCINOMA METASTATIC TO THE LIVER, ENROLLED IN THE BOOMBOX STUDY, HAD A HISTOTRIPSY TREATMENT ON (B)(6) 2025. THE PATIENT HAD A METAL STENT AND WAS DISCHARGED ON ANTIBIOTICS. ON MAY 5, 2025, THE PATIENT'S SON CALLED THE SITE AND REPORTED THAT THE PATIENT HAD EXPERIENCED NAUSEA, VOMITING, SLIGHT CONFUSION AND UNABLE TO AMBULATE AND HAD BEEN ADMITTED ON (B)(6) 2025. PER THE INVESTIGATOR'S CLINIC NOTE, THE PATIENT RECEIVED IV FLUID RESUSCITATION AND IV ZOSYN (PIPERACILLIN/TAZOBACTAM) AND WAS DISCHARGED ON (B)(6) 2025 WITH IV ERTAPENEM WITH AN END DATE OF MAY (B)(6) 2025. THE INVESTIGATOR REASSURED THE PATIENT'S SON TO DISCONTINUE ANTIBIOTICS ON (B)(6) 2025. PER THE LAST CLINIC NOTE, THE PATIENT WAS IMPROVING. PATIENT REPORTEDLY HAD A METAL STENT, THIS COULD HAVE LEAD TO CHOLANGITIS AND HYPOTENSION. THE INVESTIGATOR NOTED THAT THE ADVERSE EVENT WAS PROBABLY RELATED TO HISTOTRIPSY TREATMENT. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENT OCCURRED DURING THE PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Confusion/ Disorientation; Nausea; Vomiting

  MAUDE report 22204497 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 36-YEAR-OLD FEMALE DIAGNOSED WITH CHOLANGIOCARCINOMA (CCC) WITH LIVER METASTASES, UNDERWENT HISTOTRIPSY TREATMENT TO THREE SEPARATE TARGETS INVOLVING SEGMENTS 2,3,3/4B, FOR A TOTAL PTV OF 65 CM3. INTRAOPERATIVE ULTRASOUND IMAGING REVEALED POTENTIALLY INCOMPLETE TREATMENT OF TARGETS 1 AND 2 DUE TO ASSUMED INADEQUATE VOLTAGE THRESHOLDS ESTABLISHED DURING THE PLANNING PULSES WORKFLOW STEP. IN RESPONSE, THE TREATING PHYSICIAN PERFORMED REPEAT TREATMENTS OF THESE LESIONS USING INCREASED VOLTAGE SETTINGS WHILE MAINTAINING ORIGINAL PLANNED TREATMENT VOLUME DIMENSIONS. POST-RETREATMENT ASSESSMENT INDICATED SATISFACTORY TREATMENT OUTCOMES. DURING THE RETREATMENT OF THE SECOND TARGET, THE ANESTHESIOLOGIST OBSERVED A SMALL AMOUNT OF BLOOD IN THE URINARY CATHETER. THIS WAS SUSPECTED TO BE RELATED TO MECHANICAL IRRITATION FROM CATHETER INSERTION. THE PATIENT'S BLOOD PRESSURE TRANSIENTLY ELEVATED TO 180/100 MMHG, LIKELY SECONDARY TO THIS IRRITATION. THE PROCEDURE WAS BRIEFLY PAUSED, THE EDISON DEVICE AND SUPPORT ARM WERE REMOVED TO ALLOW ANESTHETIC EVALUATION, AND THE CATHETER WAS FLUSHED - CONFIRMING NO OBSTRUCTION. AFTER A 30-MINUTE STABILIZATION PERIOD, THE PROCEDURE RESUMED

  Patient problems: Ascites; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Liver Damage/Dysfunction; Renal Impairment

  MAUDE report 22118959 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A 64-YEAR-OLD FEMALE WITH A DIAGNOSIS OF COLORECTAL CANCER METASTATIC TO THE LIVER UNDERWENT HISTOTRIPSY TREATMENT TO FIVE SEPARATE TARGETS INVOLVING SEGMENTS 2/3, 4A/B, AND 7, FOR A TOTAL PTV OF ~161 CM3. THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POST-PROCEDURE, BOTH ULTRASOUND AND CT IMAGING REVEALED UNREMARKABLE FINDINGS WITH NO EVIDENCE OF PROCEDURAL COMPLICATIONS. HOWEVER, THE PATIENT DEVELOPED A TRANSIENT ACUTE KIDNEY INJURY (AKI), WITH SERUM CREATININE RISING FROM 47.9 MOL/L PRE-TREATMENT TO 444 MOL/L BY (B)(6), SUBSEQUENTLY NORMALIZING BY (B)(6). THE NEPHROLOGY TEAM ATTRIBUTED THE AKI TO THE HISTOTRIPSY PROCEDURE. CONCURRENTLY, THE PATIENT DEVELOPED HYPONATREMIA, WITH SERUM SODIUM LEVELS DROPPING FROM NORMAL PRE-TREATMENT VALUES TO 118 MMOL/L ON (B)(6) AND A NADIR OF 116 MMOL/L ON (B)(6), RETURNING TO NORMAL BY (B)(6). THESE ABNORMALITIES WERE MANAGED SUPPORTIVELY. THE PATIENT WAS ALSO NOTED TO HAVE ABDOMINAL DISTENSION DURING RECOVERY. AN ULTRASOUND CONFIRMED THE PRESENCE OF ASCITES. ADDITIONALLY, A CONTRAST-ENHANCED MRI WAS PERFORMED ONE DAY POST-TREATMENT FOR FURTHER EVALUATION. THE PATIENT RECEIVED A SHORT STEROID (PREDINSOLONE) T

  Patient problems: Abdominal Distention; Ascites; Hyponatremia; Renal Impairment

  MAUDE report 22118958 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF THE BOOMBOX POST-MARKET CLINICAL TRIAL, A 52 YEAR OLD FEMALE PATIENT, DIAGNOSED WITH METASTATIC LEIMYOSARCOMA, HAD A HISTOTRIPSY TREATMENT TO A SEGMENT 5 LIVER TUMOR ON (B)(6) 2025 (TOTAL PLANNED TREATMENT VOLUME (PTV) = 33.5CC ). AFTER THE HISTOTRIPSY TREATMENT, THE PATIENT EXPERIENCED SIGNIFICANT ABDOMINAL PAIN AND BROWN URINE WHICH RESULTED IN THE PATIENT BEING ADMITTED DAY OF THE PROCEDURE. A POST-PROCEDURE CT SCAN INDICATED STABLE DUODENITIS AND NO ACTIVE GASTROINTESTINAL BLEED. ACCORDING TO THE TREATING PHYSICIAN, THE DUODENUM WAS REPORTED TO BE ADJACENT AND POTENTIALLY OVERLAPPING THE PTV, WHICH MAY HAVE RESULTED IN THE PATIENT DEVELOPING DUODENITIS. THE PATIENT WAS GIVEN ANTIBIOTICS, HELD FOR OBSERVATION AND DISCHARGED ON (B)(6) 2025. AS PART OF THE BOOMBOX POST-MARKET CLINICAL TRIAL, THE TREATING PHYSICIAN DETERMINED ON (B)(6) 2025 THAT THE DUODENITIS WAS GRADE 3 DUE TO THE NEED FOR ADMISSION. THE PATIENT IS RECOVERING WELL AND NO FURTHER "SEQUELAE" WERE EXPERIENCED. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE.

  Patient problems: Abdominal Pain; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22014586 ↗
• DeathMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 81-YEAR-OLD MALE PATIENT WITH ADVANCED METASTATIC CHOLANGIOCARCINOMA RECEIVED REPEAT HISTOTRIPSY TREATMENT (INITIAL TREATMENT (B)(6) 2025, TOTAL PTV 49.0 CC) ON (B)(6) 2025, TO A SINGLE LESION IN SEGMENT V, WITH TWO PARTIALLY OVERLAPPING PLANNED TREATMENT VOLUMES (PTVS) REPORTED AS PTV 1: TOTAL PTV = 31 CC, PTV 2: TOTAL PTV = 29.5CC, FOR A TOTAL PTV OF 60.5 CC. THE PATIENT WAS DISCHARGED POST-PROCEDURE WITHOUT INCIDENT AND ULTIMATELY RETURNED HOME. ON POST-OPERATIVE DAY 3 ((B)(6) 2025), HE DEVELOPED ANURIA, AND HIS CREATININE ROSE TO 7. THE TREATING PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT HEMODIALYSIS AND HAD SOME URINE OUTPUT, WITH A DIAGNOSIS OF ACUTE TUBULAR NECROSIS (ATN) ATTRIBUTED TO A COMBINATION OF ANESTHESIA, HISTOTRIPSY, AND NSAID USE, WITH POSSIBLE CONTRIBUTION FROM ACUTE INTERSTITIAL NEPHRITIS (AIN). THE PATIENT REMAINED DIALYSIS-DEPENDENT, BUT ON-GOING HYPOTENSION COMPLICATED MANAGEMENT. THE FAMILY ULTIMATELY ELECTED TO WITHDRAW CARE AND THE PATIENT DIED ON (B)(6) 2025. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE.

  Patient problems: Low Blood Pressure/ Hypotension; Renal Impairment; Urinary Retention

  MAUDE report 22006894 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A HISTOTRIPSY TREATMENT ON (B)(6) 2025 OF A 56-YEAR-OLD FEMALE PATIENT WITH CHOLANGIOCARCINOMA METASTASES, AN ACUTE LUNG RELATED COMPLICATION WAS REPORTED. THE PATIENT WAS VENTILATED WITH A DOUBLE LUMEN INTUBATION, AND THE RIGHT LUNG HAD BEEN INTENTIONALLY ATELECTASIZED (E.G., COLLAPSED) SO ONLY THE LEFT LUNG WAS BEING VENTILATED TO IMPROVE THE ACOUSTIC IMAGING WINDOW TO THE LIVER. THE TARGETED LESION WAS IN SEGMENT 7 OF THE LIVER AND THE PATIENT WAS IN THE LATERAL DECUBITUS POSITION. THE TREATMENT WAS ABUTTING THE DIAPHRAGM, AND THE ACOUSTIC PATH ON THE CRANIAL SIDE OF THE TARGET WAS POTENTIALLY INTERACTING WITH LUNG PER THE PHYSICIAN BASED ON ULTRASOUND IMAGING. THE PLANNED TREATMENT VOLUME (PTV) PLAN DIMENSIONS WERE PRESCRIBED TO 4CMX4CMX4CM. THE PATIENT WAS ON CLOPIDOGREL (PLAVIX) AND HEPARIN PRIOR TO THE PROCEDURE. RIGHT BEFORE AUTOMATED TREATMENT (AT) WAS INITIATED, THE PHYSICIAN REQUESTED 5000 UNITS OF HEPARIN BE ADMINISTERED (AS IS STANDARD PRACTICE AT THIS FACILITY), THEN AT WAS STARTED. LESS THAN 1 MINUTE INTO TREATMENT, ANESTHESIA NOTICED BLOOD COMING OUT OF THE RIGHT LUNG INTUBATION TUBE (APPROIMATE TOTAL VOLUME OF 1 UNIT OR 0.5 LITERS). THE PHYSICIAN PAUSED TREA

  Patient problems: Hemoptysis

  MAUDE report 21857401 ↗