Habib™ EndoHPB M00500070Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729981909), received between Nov 8, 2018 and Sep 1, 2026 — classified as 1 death, 13 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 2, 2023Class IIOpen, Classified

   Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").

   Z-1397-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50534790 ↗
• MalfunctionJan 2, 2026Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HABIB ENDOHPB CATHETER WAS ATTEMPTED TO BE USED IN THE HEPATIC HILUM TO TREAT A BILE DUCT STENOSIS DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE CAUTERY OF THE FIRST HABIB CATHETER DID NOT WORK EVEN AFTER INCREASING THE OUTPUT. A SECOND HABIB CATHETER WAS USED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS ABORTED. THERE WAS NO ADVERSE EVENT REPORTED DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945222 ↗
• MalfunctionJan 2, 2026Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HABIB ENDOHPB CATHETER WAS ATTEMPTED TO BE USED IN THE HEPATIC HILUM TO TREAT A BILE DUCT STENOSIS DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CAUTERY OF THE FIRST HABIB CATHETER DID NOT WORK EVEN AFTER INCREASING THE OUTPUT. A SECOND HABIB CATHETER WAS USED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS ABORTED. THERE WAS NO ADVERSE EVENT REPORTED DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945220 ↗
• MalfunctionSep 5, 2025Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOHPB RF CATHETER WAS USED FOR ABLATION AND COAGULATION OF DIGESTIVE TRACT TISSUES DURING A RADIOFREQUENCY ABLATION PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE HEAT GENERATED BY THE TIP ELECTRODE COULD NOT REACH THE STANDARD ENERGY AND COULD NOT CAUSE TISSUE COAGULATION AND NECROSIS WELL. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979418 ↗
• MalfunctionDec 10, 2024Inadequate Instructions for Healthcare Professional; Energy Output Problem; Inadequate Instructions for Healthcare Professional; Energy Output Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A HABIB ENDOHPB CATHETER WAS USED TO TREAT AN INTRADUCTAL EXTENSION FROM AN AMPULLARY ADENOMA DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT WAS TREATED POST-AMPULLECTOMY USING AN ERBE VIO3 GENERATOR WITH A POWER SETTING OF 2.5. THE PHYSICIAN EXPRESSED CONCERN THAT THE GENERATOR SETTING IN THE ERBE VIO3 GENERATOR INSTRUCTIONS FOR USE DOES NOT ALIGN WITH CLINICAL RECOMMENDATIONS REGARDING USE OF REDUCED POWER IN CRITICAL ANATOMY AND MAY CAUSE SEVERE PATIENT COMPLICATIONS. WHEN THE HABIB ENDOHPB CATHETER PROBE WAS ENERGIZED DURING THE PROCEDURE, DENATURING OF THE DUODENAL TISSUE AT THE AMPULLARY ORIFICE WAS OBSERVED ON THE ENDOSCOPIC MONITOR, SUGGESTING THAT THE ABLATION DEPTH WAS GREATER THAN INTENDED. THE PATIENT WAS MONITORED, BUT NO INTERVENTION OR TREATMENT WAS PERFORMED TO ADDRESS THE REPORTED DENATURING OF THE DUODENAL TISSUE. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20896425 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING HABIB ENDOHPB BIPOLAR RADIOFREQUENCY CATHETER THROUGH THE ARTICLE TITLED, "COMPARISON BETWEEN REGULAR ADDITIONAL ENDOBILIARY RADIOFREQUENCY ABLATION AND PHOTODYNAMIC THERAPY IN PATIENTS WITH ADVANCED EXTRAHEPATIC CHOLANGIOCARCINOMA UNDER SYSTEMIC CHEMOTHERAPY" BY CHRISTIAN MOHRING, ET AL., PER THE ARTICLE, BETWEEN JANUARY 2006 TO DECEMBER 2021 THE FOLLOWING OCCURRED WITH STUDY PATIENTS: LEUKOPENIA, THROMBOPENIA, ANEMIA, NEUTROPENIA, OTHER HEMATOTOXIC SIDE EFFECTS, ALT ELEVATION, ASCITES, HEPATIC DYSFUNCTION, ANOREXIA, FATIGUE, NAUSEA, VOMIT, CREATININE ELEVATION, CHRONIC KIDNEY FAILURE, SKIN RASH, DIARRHEA, ALLERGIC REACTION, INFECTION WITHOUT NEUTROPENIA, INFECTION WITH NEUTROPENIA, DEEP VEIN THROMBOSIS, THROMBOEMBOLIC EVENT, HYPERBILIRUBINEMIA, JAUNDICE, ABDOMINAL PAIN, CHOLANGITIS, BILIARY SEPSIS, INFECTION (OTHER THAN CHOLANGITIS), WEIGHT LOSS, PAINS, PLEURAL EFFUSION, HYPERTENSION, ILEUS, PHOTOTOXIC REACTION AND FEVER. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS AND FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

  Patient problems: Abdominal Pain; Anemia; Ascites; Cholangitis; Decreased Appetite; Diarrhea; Fatigue; Fever; High Blood Pressure/ Hypertension; Hyperbilirubinemia; Hypersensitivity/Allergic reaction; Insufficient Information; Jaundice; Liver Damage/Dysfunction; Low White Blood Cell Count; Nausea; Pain; Pleural Effusion; Rash; Renal Failure; Sepsis; Thrombocytopenia; Thromboembolism; Thrombosis/Thrombus; Unspecified Infection; Vomiting; Weight Changes

  MAUDE report 20173007 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A HABIB EUS RFA CATHETER THROUGH THE ARTICLE, ENDOLUMINAL RADIOFREQUENCY ABLATION IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION: A RANDOMISED TRIAL, BY JANA JAROSOVA, ET AL. PER THE ARTICLE, A HABIB EUS RFA CATHETER WAS USED TO TREAT CHOLANGIOCARCINOMA AND PANCREATIC DUCTAL ADENOCARCINOMA DURING AN ENDOLUMINAL RADIOFREQUENCY ABLATION (RFA) PLUS STENTING PERFORMED BETWEEN 2016 AND 2021. ONE PATIENT DEVELOPED MILD POST-PROCEDURAL PANCREATITIS. FOUR PATIENTS DEVELOPED ACUTE CHOLANGITIS AND WERE SUCCESSFULLY TREATED WITH ANTIBIOTICS. THE CHOLANGITIS OCCURRED EARLY AFTER THE PROCEDURE IN TWO OF THOSE FOUR PATIENTS, REQUIRING A REPEATED INTERVENTION. FURTHERMORE, ONE PATIENT WITH ACUTE CHOLANGITIS GOT COMPLICATED BY THE DEVELOPMENT OF A LIVER ABSCESS BUT WAS SUCCESSFULLY TREATED WITH PERCUTANEOUS DRAINAGE. LASTLY, ONE PATIENT DEVELOPED CHOLECYSTITIS, WHICH WAS RESOLVED WITH INTRAVENOUS ANTIBIOTICS. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

  Patient problems: Abscess; Cholangitis; Inflammation; Pancreatitis

  MAUDE report 20041035 ↗
• MalfunctionMay 13, 2024Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PATIENT AND PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02142, 3005099803-2024-02143, AND 3005099803-2024-02145 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HABIB ENDOHPB RF CATHETER WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE HABIB CATHETER (THE SUBJECT OF THIS REPORT) WAS TRIED TO ABLATE A TISSUE OVERGROWTH ON A BOSTON SCIENTIFIC METAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2024-02145); HOWEVER, THE PROBE WAS UNABLE TO DELIVER ENERGY. ANOTHER HABIB ENDOHPB RF CATHETER (THE SUBJECT OF MFR. REPORT # 3005099803-2024-02143) WAS USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298959 ↗
• MalfunctionMay 13, 2024Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PATIENT AND PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-02142, 3005099803-2024-02143, AND 3005099803-2024-02145 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HABIB ENDOHPB RF CATHETER WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE HABIB CATHETER (THE SUBJECT OF MFR. REPORT # 3005099803-2024-02142) WAS TRIED TO ABLATE A TISSUE OVERGROWTH ON A BOSTON SCIENTIFIC METAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2024-02145); HOWEVER, THE PROBE WAS UNABLE TO DELIVER ENERGY. ANOTHER HABIB ENDOHPB RF CATHETER (THE SUBJECT OF THIS REPORT) WAS USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298957 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # MFR. REPORT # 3005099803-2024-01884). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOHPB RF CATHETER WAS USED, AND AN EPIC BILIARY STENT WAS IMPLANTED TO TREAT A MALIGNANT BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE IN THE PROXIMAL COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, IT WAS NOTED THAT THE EPIC BILIARY STENT (SUBJECT OF MANUFACTURER REPORT # 3005099803-2024-01884) WAS OCCLUDED. AN ENDOHPB RF CATHETER (SUBJECT OF THIS REPORT) WAS THEN USED TO ABLATE WITHIN THE EPIC BILIARY STENT. ON (B)(6) 2023, THE PATIENT WAS BEING UNWELL AND PRESENTED WITH CHOLANGITIS. IV ZOSYN AND CIPROFLOXACIN WERE THEN ADMINISTERED. INTERVENTIONAL RADIOLOGY (IR) WAS PERFORMED BY PLACING A DRAIN FOR HEPATIC FLUID COLLECTION. SEPSIS WORKUP SHOWED KLEBSIELLA PNEUMONIA BACTEREMIA, PAIN MANAGEMENT WAS DONE, AND CHEMOTHERAPY WAS CONTINUED. THE PATIENT IS REPORTED TO BE STABLE IN CONTEXT OF MALIGNANT NEOPLASM OF TRANSVERSE COLON.

  Patient problems: Bacterial Infection; Cholangitis; Pain

  MAUDE report 19183252 ↗
• MalfunctionOct 17, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HABIB ENDOHPB RF CATHETER WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH RADIOFREQUENCY ABLATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE HABIB CATHETER WAS CONNECTED WITH THE CONNECTION CABLE; HOWEVER, WHEN TRYING TO APPLY ENERGY, THE DEVICE FAILED TO DELIVER ENERGY AND THE ERBE GENERATOR DID NOT RECOGNIZE THE DEVICE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 09, 2023 AND OCTOBER 17, 2023. IT WAS FOUND THAT THE PROBLEM WAS ON THE CONNECTION CABLE FROM THE GENERATOR TO THE HABIB PROBE. REPORTEDLY, THE CONNECTION CABLE WAS REPLACED AND THE FOLLOWING PROCEDURE WITH ANOTHER HABIB PROBE WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953099 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A HABIB ENDOHPB RADIO FREQUENCY ABLATION CATHETER THROUGH THE ARTICLE "HYPERKALEMIA AFTER ENDOBILIARY RADIOFREQUENCY ABLATION FOR MALIGNANT BILIARY OBSTRUCTION", BY INOUE T, ET AL. ACCORDING TO THE LITERATURE, ENDOSCOPIC TRANSPAPILLARY DRAINAGE FAILED BECAUSE OF TUMOR INVASION TO THE DUODENUM, AND ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE WAS ATTEMPTED. AFTER PENETRATING THE LEFT INTRAHEPATIC DUCT VIA THE STOMACH, A GUIDEWIRE WAS PASSED THROUGH THE LOWER BILE DUCT STRICTURE. THE FISTULA WAS DILATED USING A 4-MM DILATATION BALLOON CATHETER, AND A HABIB ENDOHPB RADIO FREQUENCY ABLATION CATHETER WAS INSERTED. SUBSEQUENTLY, THE STRICTURE WAS ABLATED AT A POWER OF 7 WATTS FOR 90 SECONDS. A METALLIC STENT WAS DEPLOYED ANTEGRADE ACROSS THE STRICTURE, AND A SINGLE-PIGTAIL PLASTIC STENT WAS DEPLOYED ACROSS THE FISTULA. THE PATIENTS VITAL SIGNS WERE STABLE DURING THE PROCEDURE. HOWEVER, SEVERE BRADYCARDIA OCCURRED 2 HOURS LATER WITH THEIR HEART RATE PLUMMETING BELOW 20 TO 30 BEATS PER MINUTE (BPM) AND ELECTROCARDIOGRAM SHOWING FLATTENED P-WAVES AND PROLONGED QRS COMPLEX. A BLOOD TEST REVEALED SERUM POTASSIUM LEVELS OF 7.4 MEQ/L, WHICH HAD BEEN

  Patient problems: Bradycardia; Hyperkalemia; Non specific EKG/ECG Changes

  MAUDE report 17571246 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT #3005099803-2023-04100). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOHPB RF CATHETER WAS USED, AND AN ADVANIX BILIARY STENT WAS IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, AT AN OUTSIDE HOSPITAL (OSH) THE PATIENT PRESENTED WITH CHOLANGITIS. ON (B)(6) 2023, THE PATIENT WAS ADMITTED AND WAS ADMINISTERED ANTIBIOTICS AND FLUIDS DURING THEIR STAY. ON (B)(6) 2023, THE IMPLANTED ADVANIX STENT WAS SUCCESSFULLY REMOVED DURING AN ERCP PROCEDURE, AND A NEW ADVANIX BILIARY STENT WAS PLACED. ON (B)(6) 2023, THE PATIENT WAS DISCHARGED WITH CONTINUOUS ANTIBIOTICS. IT IS NOT KNOWN WHETHER THE ADVANIX BILIARY STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2023-04100) OR THE ENDOHPB RF CATHETER MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S COMPLICATION OF CHOLANGITIS. THE PATIENT IS REPORTED TO BE CURRENTLY WELL IN THE CONTEXT OF HAVING TERMINAL CANCER.

  Patient problems: Cholangitis

  MAUDE report 17459629 ↗
• MalfunctionAug 3, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT A HABIB ENDOHPB RF CATHETER WAS USED TO TREAT AN INOPERABLE AMPULLARY MALIGNANT TUMOR DURING A RADIOFREQUENCY ABLATION PROCEDURE PERFORMED ON (B)(6) 2023. THE LESION WAS NOT DILATED PRIOR TO THE FIRST ATTEMPT AT ABLATION. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO DELIVER ENERGY AND THE LESION COULD NOT BE ABLATED. FURTHERMORE, THERE WAS NO BLANCHING OF THE TISSUE NOTED. THE PROCEDURE WAS NOT COMPLETED DUE TO THE AVAILABILITY OF THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449970 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A HABIB ENDOHPB RADIOFREQUENCY CATHETER THROUGH THE ARTICLE GASTROINTESTINAL: PANCREATIC DUCT PERFORATION FOLLOWING ENDOSCOPIC INTRADUCTAL RADIOFREQUENCY ABLATION FOR PANCREATIC DUCT STRICTURE. ACCORDING TO THE LITERATURE, A HABIB RADIOFREQUENCY CATHETER WAS USED DURING AN INTRADUCTAL RADIOFREQUENCY ABLATION PROCEDURE TO TREAT A PANCREATIC STRUCTURE. IT WAS REPORTED THAT THE PATIENT'S PANCREATIC STRICTURE HAD BEEN PREVIOUSLY TREATED TWICE BY TEMPORARY STENT PLACEMENT; HOWEVER, THE SYMPTOMATIC STRICTURE RECURRED. THEREFORE, ENDOSCOPIC RADIOFREQUENCY ABLATION (RFA) FOR THE STRICTURE WAS PLANNED TO OBTAIN LONG-TERM RESOLUTION. FOLLOWING PANCREATIC DUCT CANNULATION AND GUIDEWIRE PLACEMENT, A HABIB ENDOHPB CATHETER WAS INSERTED OVER THE GUIDEWIRE. RFA WAS PERFORMED ON THE PANCREATIC HEAD DUCT STRICTURE FOR 90 SECONDS AT A POWER OF 7 WATTS. FOLLOWING RFA, AN 8.5-FR PLASTIC STENT WAS PLACED ACROSS THE STRICTURE. THERE WERE NO ADVERSE EVENTS. FOUR MONTHS LATER, A PANCREATIC DUCT PERFORATION WAS OBSERVED BASED ON THE OVERFLOW OF THE CONTRAST MEDIUM TO THE OUTSIDE OF THE PANCREATIC DUCT POST-STENT REMOVAL. THEREFORE, A PLASTIC STENT WAS PL

  Patient problems: Perforation

  MAUDE report 17449778 ↗
• InjuryMar 24, 2023Energy Output Problem; Energy Output Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 06, 2023 THAT A HABIB ENDOHPB RF CATHETER WAS USED IN THE PAPILLA TO TREAT AN INTRADUCTAL ADENOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH RADIOFREQUENCY ABLATION (RFA). THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT AND THE PROCEDURE WAS PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AN UNUSUAL LARGE-AREA ENERGY WAS RELEASED WITH NECROSIS TO THE ADJACENT TISSUE. A METAL STENT WAS PLACED TO PREVENT STENOSIS AND BLEEDING AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2023., POST PROCEDURE, AN ENDOSCOPIC PROCEDURE WAS PERFORMED DUE TO SIGNS OF BLOOD LOSS (LOW HEMOGLOBIN AND MELENA). SUBSEQUENTLY, THE PATIENT WAS INJECTED WITH SUPRARENIN SOLUTION FOR HEMOSTASIS DUE TO BLEEDING. ON (B)(6) 2023., DURING A CONTROL VISIT, IT WAS NOTED THAT THE BLEEDING WAS RESOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16611292 ↗
• MalfunctionMar 21, 2023Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT#: 3005099803-2023-01502 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 02, 2023 THAT A HABIB ENDOHPB CATHETER WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE HABIB ENDOHPB CATHETER (THE SUBJECT OF MFR. REPORT#: 3005099803-2023-01502) WAS UNABLE TO DELIVER ENERGY. THE DEVICE WAS TRIED IN SALINE OUTSIDE THE PATIENT BUT IT WAS STILL UNABLE TO DELIVER ENERGY. A SECOND HABIB ENDOHPB CATHETER (THE SUBJECT OF THIS REPORT) WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE OUTCOME OF THE PROCEDURE WAS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584997 ↗
• MalfunctionMar 21, 2023Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT#: 3005099803-2023-01501 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 02, 2023 THAT A HABIB ENDOHPB CATHETER WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE HABIB ENDOHPB CATHETER (THE SUBJECT OF THIS REPORT) WAS UNABLE TO DELIVER ENERGY. THE DEVICE WAS TRIED IN SALINE OUTSIDE THE PATIENT BUT IT WAS STILL UNABLE TO DELIVER ENERGY. A SECOND HABIB ENDOHPB CATHETER (THE SUBJECT OF MFR.#: 3005099803-2023-01501) WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE OUTCOME OF THE PROCEDURE WAS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584995 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING A HABIB RF CATHETER THROUGH THE ARTICLE "ENDOSCOPIC RADIOFREQUENCY ABLATION FOR MALIGNANT BILIARY OBSTRUCTION: A NATIONWIDE RETROSPECTIVE STUDY OF 84 CONSECUTIVE APPLICATIONS" BY DR. WERNER DOLAK, ET AL. A TOTAL OF 58 PATIENTS UNDERWENT 84 RADIOFREQUENCY ABLATION PROCEDURES TO TREAT A MALIGNANT BILIARY OBSTRUCTION PERFORMED IN BETWEEN NOVEMBER 2010 AND DECEMBER 2012. ALL 84 RFA PROCEDURES WERE CONDUCTED WITHOUT ANY TECHNICAL PROBLEMS; 78 WERE PERFORMED VIA ERCP AND 6 WERE PERFORMED VIA A PERCUTANEOUS APPROACH. A TOTAL OF 15 RFA PROCEDURES WERE PERFORMED WITHIN A PREVIOUSLY IMPLANTED SELF-EXPANDING METAL STENT. ACCORDING TO THE LITERATURE, ON ONE RFA PROCEDURE, A 10W WAS APPLIED FOR 90 SECONDS AT SIX DIFFERENT STRICTURE LOCATIONS IN THE COMMON BILE DUCT AND BOTH MAIN BILIARY BRANCHES. HOWEVER, A PARTIAL LIVER INFARCTION WAS NOTED AFTER THE RFA PROCEDURE. IT IS UNKNOWN HOW THE PARTIAL LIVER INFARCTION WAS ADDRESSED AND THE PATIENT WAS DISCHARGED AFTER 8 DAYS. FURTHERMORE, A COMPUTER TOMOGRAPHY SCAN (CT) WAS PERFORMED 3 MONTHS POST RFA PROCEDURE AND IT SHOWED NORMAL PERFUSION OF THE AFFECTED LIVER AREAS.

  Patient problems: Burn(s)

  MAUDE report 16269103 ↗
• MalfunctionDec 16, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN ENDOHPB RF CATHETER WAS USED IN THE BILE DUCT FOR STENT INGROWTH DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH RADIOFREQUENCY ABLATION PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO FIRST ATTEMPT AT ABLATION. DURING THE PROCEDURE, THE HABIB CATHETER WAS UNABLE TO DELIVER ENERGY. THE DEVICE WAS REPOSITIONED AND THE POWER SETTING WAS INCREASED; HOWEVER, THE HABIB CATHETER WAS STILL UNABLE TO WORK. THE PROCEDURE WAS CANCELLED DUE TO DEVICE AVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999737 ↗
• InjuryJul 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A HABIB ENDOHPB RF CATHETER WAS USED IN THE BILIARY TREE-HEPATIC DUCT TO ABLATE A MALIGNANT BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT AND DIFFICULT TO TRAVERSE. DURING THE PROCEDURE, THE ENDOHPB RF CATHETER WAS ABLE TO ABLATE THREE DIFFERENT AREAS; HOWEVER, UPON REMOVAL OF THE RFA CATHETER, THE TWO STAINLESS STEEL ELECTRODES DETACHED AND REMAINED IN THE PATIENT'S DUCT. THE TWO STAINLESS STEEL ELECTRODES WAS SWEPT USING A BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15017709 ↗
• DeathJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A HABIB ENDOHPB RF CATHETER WAS USED WITHOUT ISSUES IN THE BILE DUCT DURING A BILE DUCT RADIO FREQUENCY TREATMENT PERFORMED ON (B)(6) 2022. THE HABIB ENDOHPB RF CATHETER WAS BEING USED TO TREAT A LOCALIZED BILIARY MALIGNANCY. ABOUT 10 DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH CHOLANGITIS ACCOMPANIED WITH A 40 DEGREES CELSIUS FEVER. THE PATIENT WAS TREATED WITH ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) ANTIBIOTICS AND WAS NOTED TO HAVE RECOVERED. LATER (EXACT DATE UNKNOWN), THE PATIENT AGAIN PRESENTED WITH CHOLANGITIS AND A PORTAL VEIN THROMBOSIS WAS DISCOVERED. THEN A CORONARY ANEURYSM FROM ANOTHER THROMBOSIS WAS NOTED. THE CORONARY ANEURYSM COULD NOT BE APPROACHED AND THE THROMBOSIS COULD NOT BE REMOVED. THE PATIENT EXPERIENCE LIVER FAILURE DUE TO THROMBOSIS. ON (B)(6) 2022, THE PATIENT DIED DUE TO LIVER FAILURE. IN THE PHYSICIAN'S ASSESSMENT, PATIENT'S DEATH COULD BE RELATED TO THE HABIB TREATMENT.

  Patient problems: Aneurysm; Fever; Inflammation; Liver Damage/Dysfunction; Thrombosis/Thrombus

  MAUDE report 14918970 ↗
• InjuryApr 21, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A HABIB ENDOHPB RF CATHETER WAS USED TO TREAT A HILAR BILE DUCT STENOSIS DURING A RADIOFREQUENCY ABLATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE WAS ABLE TO CAUTERIZE THE RIGHT HEPATIC DUCT; HOWEVER, THERE WAS DIFFICULTY IN REMOVING THE CATHETER. EVENTUALLY, THE CATHETER WAS PULLED OUT WITH FORCE. THE PHYSICIAN THEN CAUTERIZED THE LEFT HEPATIC DUCT BUT THE CATHETER WAS AGAIN DIFFICULT TO REMOVE. THE CATHETER WAS REMOVED WITH FORCE, AND THE ELECTRODE DETACHED AND FELL IN THE BILE DUCT. THE ELECTRODE WAS ATTEMPTED TO BE REMOVED WITH FORCEPS BUT IT FELL ON THE LIVER SIDE OF THE STENOSIS. THE DETACHED ELECTRODE REMAINED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14172638 ↗
• MalfunctionApr 8, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 17, 2022 THAT A HABIB ENDOHPB RF CATHETER WAS TO BE USED TO ABLATE AN AMPULLARY TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE PROBE HAD NO ENERGY AND WAS UNABLE TO ABLATE INSIDE THE PATIENT DESPITE SECURED CONNECTIONS. THE DEVICE WAS TESTED OUTSIDE THE PATIENT BUT THERE WAS NO ENERGY. THE PROCEDURE WAS NOT COMPLETED DUE TO DEVICE AVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14059315 ↗
• MalfunctionNov 29, 2021Failure to Deliver Energy; Appropriate Device Problem Term/Code Not Available; Failure to Deliver Energy; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 09, 2021 THAT A HABIB ENDOHPB RF CATHETER WAS TO BE USED TO TREAT TUMOR INGROWTH IN THE HILAR BILE DUCT DURING A BILIARY RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CATHETER DID NOT DELIVER ENERGY FOR ABLATION. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12887538 ↗