Dreamtome™ RX 44 M00584040Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 08714729778264), received between Feb 24, 2017 and Sep 17, 2026 — classified as 4 injuries, 161 malfunctions.

The most frequently reported specific device problem is “Break” (122 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. Dec 22, 2021Class IIOpen, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0751-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Failure to Fold; Deformation Due to Compressive Stress

  It was reported to Boston Scientific Corporation that a Dreamtome RX 44 was attempted to be used during an Endoscopic retrograde cholangiopancreatography (ERCP) procedure to treat stones performed on (b)(6)2026. During the procedure, the tech mentioned that they were having a hard time bowing the device fully, and that the handle felt like it was sticking. After sphincterotomy was performed and the device was unbowed, it was observed that one side of the cutting wire became dislodged and was sticking out. The procedure was completed with the original device. There was no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803739 ↗
• MalfunctionSep 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744193 ↗
• MalfunctionSep 9, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700941 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A DREAMTOME CUT WIRE BROKE WHEN TRYING TO PERFORM A SPHINCTEROTOMY. IT WAS REPORTED THAT NO CUTTING WIRE WAS DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818938 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456315 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLANGITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN ATTEMPTING TO DO THE SPHINCTEROTOMY THE CUTTING WIRE BROKE UPON ACTIVATION OF THE DIATHERMY. IT WAS REPORTED THAT NO PART OF THE DEVICE WAS DETACHED AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331960 ↗
• MalfunctionSep 18, 2025Failure to Align; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Align; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED THROUGH THE DUODENOSCOPE. THE TIP OF THE TOME CANNULATED THE AMPULLA AND THE WIRE WAS FED INTO THE DUCT. WHEN THE DEVICE WAS ADVANCED INTO THE AMPULLA TO CREATE A SPACE BETWEEN THE TOME AND THE SCOPE FOR SPHINCTEROTOMY, THE TECHNICIAN BOWED THE TOME, AND THE CUTTING WIRE STARTED TO GO UNDER TOME AND TIP OF THE TOME MADE THE FORM OF A Z. THIS CREATED UNNECESSARY FORCE ON THE AMPULLA IN A MORE VASCULAR AREA ON THE AMPULLA. THE DEVICE WAS REMOVED AND MANUALLY STRAIGHTENED AND BOWED OUTSIDE THE SCOPE WITH NO PROBLEM. WHEN PLACED BACK THROUGH THE SCOPE AND OUT OF THE WORKING CHANNEL, THE SAME PROBLEM OCCURRED WHERE THE TOME MADE THE FORM OF A Z. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS REPORTED THAT THERE WAS A PATIENT BLEED THAT WAS ADDRESSED WITH A MECHANICAL TAMPONADE WITH BALLOON. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23092520 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUSTOMER INSERTED THE DREAMTOME, PLACED IT FOR CUTTING, THE DEVICE WAS BOWED WITHOUT ENERGY ON IT, AND THE WIRE BROKE BEFORE CUTTING WAS STARTED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022538 ↗
• MalfunctionSep 4, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED AND PLACED FOR CUTTING. THE DEVICE WAS BOWED, AND CURRENT WAS NOT APPLIED HOWEVER THE CUT WIRE BROKE BEFORE CUTTING HAS STARTED. ANOTHER DREAMTOME RX 44 WAS USED BUT THE WIRE BROKE AGAIN. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PHYSICIAN STOPPED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22973987 ↗
• MalfunctionSep 4, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INSERTED AND PLACED FOR CUTTING. THE DEVICE WAS BOWED, AND CURRENT WAS NOT APPLIED HOWEVER THE CUT WIRE BROKE BEFORE CUTTING HAS STARTED. ANOTHER DREAMTOME RX 44 WAS USED BUT THE WIRE BROKE AGAIN. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PHYSICIAN STOPPED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22973863 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE BROKE DURING CAUTERY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318790 ↗
• InjuryApr 29, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) RENDEZVOUS PROCEDURE WITH INTERVENTIONAL RADIOLOGY (IR) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, INTERVENTIONAL RADIOLOGY HAD PLACED A GUIDEWIRE PERCUTANEOUSLY INTO THE DUODENUM. THE WIRE STRAIGHTENED OUT THE AMPULLA SO IT COULD BE CANNULATED WITH THE DREAMTOME RX 44. A SPHINCTEROTOMY WAS PERFORMED, THE CUTTING WIRE SNAPPED, AND THE IR WIRE WAS CUT CLEAN. IT WAS REPORTED THAT A PORTION (.014 INCHES) OF THE IR WIRE DETACHED AND FELL INTO THE PATIENT BUT WAS SUCCESSFULLY RETRIEVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE CUTTING WIRE WAS BROKEN. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATES THAT THE CUTTING WIRE SHOULD BE FULLY EXITED THE ENDOSCOPE BEFORE APPLYING ELECTROCAUTERY CURRENT. HOWEVER, THE CUSTOMER REPORTED THAT THE CUTTING WIRE HAD NOT FULLY EXITED THE ENDOSCOPE BEFORE THE DEVICE WAS ENERGI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930524 ↗
• MalfunctionApr 15, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE CUTTING WIRE BROKE POST-SPHINCTEROTOMY AND WAS IMMEDIATELY REMOVED FROM THE PATIENT. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21841022 ↗
• MalfunctionApr 2, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE LOWER BILE DUCT DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE OF THE SPHINCTEROTOME SPLIT DURING THE SPHINCTEROTOMY. IT WAS ALSO REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21757484 ↗
• MalfunctionMar 21, 2025Break; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA AND DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WAS DOING A SPHINCTEROTOMY WITH CAUTERY AND THE CUTTING WIRE BROKE OFF. A PHOTO OF THE DEVICE INSIDE THE POUCH WAS PROVIDED BY THE COMPLAINANT WHERE IT CAN BE SEEN THAT THE CUTTING WIRE WAS BROKEN AND KINKED. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE COMPLAINANT REPORTED THAT THERE MIGHT HAVE BEEN A BRIEF MOMENT WHEN THE CUTTING WIRE WAS NOT IN CONTACT WITH THE TISSUE WHILE ENERGIZED OR USING CAUTERY; HOWEVER, PER THE INSTRUCTIONS FOR USE (IFU), PRECAUTION: IT IS RECOMMENDED TO MAINTAIN DIRECT AND CONSTANT CONTACT WITH TISSUE WHEN APPLYING ELECTROCAUTERY CURRENT. FAILURE TO DO SO MAY RESULT IN BROKEN CUT WIRE, DAMAGE TO THE ENDOSCOPE AND/OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664389 ↗
• MalfunctionMar 6, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE COMMON BILE DUCT (CBD) DURING A SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE WHEN THE PHYSICIAN PERFORMED SPHINCTEROTOMY FOR A GALLSTONE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542841 ↗
• MalfunctionMar 5, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531133 ↗
• MalfunctionFeb 25, 2025Unsealed Device Packaging; Unsealed Device Packaging

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES THAT WERE RECEIVED IN THE SAME SHIPMENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SHIPMENT OF DREAMTOME RX 44 DEVICES WERE RECEIVED BY THE HEALTHCARE FACILITY ON (B)(6) 2025. IT WAS NOTED THAT THREE DREAMTOME RX 44 DEVICES OF THE SAME LOT NUMBER CONTAINED WATER DAMAGE INSIDE THE SEALED PACKAGING. IT WAS REPORTED THAT THERE WERE NO VISIBLE TEARS, RIPS OR HOLES NOTED ON THE DEVICE PACKAGING. THE DEVICE WAS NEVER IN SERVICE AND THERE WERE NO PATIENTS INVOLVED IN THIS EVENT. PHOTOS OF THE COMPLAINT DEVICES WERE PROVIDED BY THE CUSTOMER AND SHOW WATER DAMAGE ALONG THE SEAMS OF THE EXTERNAL DEVICE SHIPPING BOX. THREE DEVICE PHOTOS ALSO SHOW THE STERILE DEVICE POUCHES HAVE VISIBLE WATER RESIDUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459927 ↗
• MalfunctionFeb 25, 2025Unsealed Device Packaging; Unsealed Device Packaging

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES THAT WERE RECEIVED IN THE SAME SHIPMENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SHIPMENT OF DREAMTOME RX 44 DEVICES WERE RECEIVED BY THE HEALTHCARE FACILITY ON JANUARY 31, 2025. IT WAS NOTED THAT THREE DREAMTOME RX 44 DEVICES OF THE SAME LOT NUMBER CONTAINED WATER DAMAGE INSIDE THE SEALED PACKAGING. IT WAS REPORTED THAT THERE WERE NO VISIBLE TEARS, RIPS OR HOLES NOTED ON THE DEVICE PACKAGING. THE DEVICE WAS NEVER IN SERVICE AND THERE WERE NO PATIENTS INVOLVED IN THIS EVENT. PHOTOS OF THE COMPLAINT DEVICES WERE PROVIDED BY THE CUSTOMER AND SHOW WATER DAMAGE ALONG THE SEAMS OF THE EXTERNAL DEVICE SHIPPING BOX. THREE DEVICE PHOTOS ALSO SHOW THE STERILE DEVICE POUCHES HAVE VISIBLE WATER RESIDUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459898 ↗
• MalfunctionFeb 25, 2025Unsealed Device Packaging; Unsealed Device Packaging

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES THAT WERE RECEIVED IN THE SAME SHIPMENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SHIPMENT OF DREAMTOME RX 44 DEVICES WERE RECEIVED BY THE HEALTHCARE FACILITY ON JANUARY 31, 2025. IT WAS NOTED THAT THREE DREAMTOME RX 44 DEVICES OF THE SAME LOT NUMBER CONTAINED WATER DAMAGE INSIDE THE SEALED PACKAGING. IT WAS REPORTED THAT THERE WERE NO VISIBLE TEARS, RIPS OR HOLES NOTED ON THE DEVICE PACKAGING. THE DEVICE WAS NEVER IN SERVICE AND THERE WERE NO PATIENTS INVOLVED IN THIS EVENT. PHOTOS OF THE COMPLAINT DEVICES WERE PROVIDED BY THE CUSTOMER AND SHOW WATER DAMAGE ALONG THE SEAMS OF THE EXTERNAL DEVICE SHIPPING BOX. THREE DEVICE PHOTOS ALSO SHOW THE STERILE DEVICE POUCHES HAVE VISIBLE WATER RESIDUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459885 ↗
• MalfunctionDec 30, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE AMPULLA IN DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE DUODENOSCOPE, ADVANCED THE SCOPE TO THE AMPULLA. CANNULATED SUCCESSFULLY BUT WHEN THE PHYSICIAN WANTED TO DO SPHINCTEROTOMY THE CUTTING WIRE BROKE WHILE ACTIVATING THE ERBE 300 DIATHERMY. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE EXPOSED CUTTING WIRE WAS NOT FULLY EXITED THE ENDOSCOPE WHEN THE DEVICE WAS ENERGIZED; HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), VERIFY THAT THE CUTTING WIRE HAS EXITED THE ENDOSCOPE BY VISUALIZING IT ON THE ENDOSCOPE MONITOR. FAILURE TO DO SO MAY RESULT IN CONTACT BETWEEN THE CUTTING WIRE AND THE ENDOSCOPE WHILE ELECTRICAL CURRENT IS APPLIED. THIS MAY CAUSE GROUNDING, WHICH CAN RESULT IN PATIENT INJURY, OPERATOR INJURY, A BROKEN CUTTING WIRE, AND/OR DAMAGE TO THE ENDOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21041256 ↗
• MalfunctionDec 11, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TOME WAS INITIALLY USED TO MAKE THE FIRST CUT AND THEN IT WAS REMOVED FROM THE SCOPE. LATER IN THE CASE, IT WAS REINTRODUCED THROUGH THE SCOPE INTO THE PATIENT'S DUODENUM, WHERE IT WAS NOTED THAT THE WIRE HAD BROKEN. IT WAS REPORTED THAT THE CUTTING WIRE REMAINED CONNECTED TO THE CATHETER AND DID NOT FALL INTO THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909187 ↗
• MalfunctionDec 10, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024 . DURING THE PROCEDURE, THE DEVICE WAS USED TO MAKE AN INITIAL CUT AND THEN REMOVED FROM THE SCOPE. LATER IN THE CASE, THE DEVICE WAS REINTRODUCED THROUGH THE SCOPE AND INTO THE DUODENUM OF THE PATIENT AND IT WAS NOTED THAT THE CUTTING WIRE BROKE. THE CUTTING WIRE WAS STILL CONNECTED TO THE CATHETER AND NO PART DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATES THAT THIS DEVICE IS FOR SINGLE USE ONLY AND SHOULD NOT BE REUSED, REPROCESSED OR RESTERILIZED. HOWEVER, THE CUSTOMER REPORTED THAT THE DEVICE WAS USED INSIDE THE PATIENT, REMOVED, AND THEN REINTRODUCED LATER IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893944 ↗
• MalfunctionNov 13, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 WAS ATTEMPTED TO BE USED IN THE AMPULLA AND COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE DUODENOSCOPE AND NAVIGATED TO THE AMPULLA. THE TOME CAME OUT OF THE DUODENOSCOPE CHANNEL, AND HE CANNULATED SUCCESSFULLY. WHEN THEY STARTED TO ACTIVATE THE DIATHERMY FOR SPHINCTEROTOMY, THE CUTTING WIRE BROKE IN THE MIDDLE BUT WAS STILL ATTACHED TO THE WIRE ANCHORS DISTALLY AND PROXIMALLY. IT WAS REPORTED THAT NO PART OF THE WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX 44. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE EXPOSED CUTTING WIRE WAS NOT FULLY EXITED THE ENDOSCOPE WHEN THE DEVICE WAS ENERGIZED; HOWEVER, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), VERIFY THAT THE CUTTING WIRE HAS EXITED THE ENDOSCOPE BY VISUALIZING IT ON THE ENDOSCOPE MONITOR. FAILURE TO DO SO MAY RESULT IN CONTACT BETWEEN THE CUTTING WIRE AND THE ENDOSCOPE WHILE ELECTRICAL CURRENT IS APPLIED. THIS MAY CAUSE GROUNDING, WHICH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678493 ↗
• MalfunctionSep 25, 2024Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04635 FOR THE RX LOCKING / BIOPSY CAP AND REPORT NUMBER FOR THE DREAMTOME RX 44. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT FOR THE TREATMENT OF STONES. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS THE DREAMWIRE DOWN THE SCOPE. SEVERAL INTERVENTIONS WERE ATTEMPTED; HOWEVER, IT WAS UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE RESCHEDULED PROCEDURE WAS COMPLETED BY PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY. WHEN THE SCOPE WAS CHECKED THE FOLLOWING DAY, A PIECE OF FOAM FROM THE BIOPSY CAP WAS PULLED OUT OF THE WORKING PORT. IT IS UNKNOWN IF A WATER-SOLUBLE LUBRICANT WAS APPLIED ON THE BIOPSY CAP PRIOR TO USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301703 ↗