RX Needle Knife XL M00545840Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 08714729283799), received between Dec 23, 2016 and Sep 22, 2026 — classified as 42 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Break” (75 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Deformation Due to Compressive Stress

  It was reported to Boston Scientific Corporation that an RX Needle Knife XL was attempted to be used in the Common Bile Duct during an Endoscopic Retrograde Cholangiopancreatography procedure to treat Stones performed on (b)(6)2026. During the procedure, when the catheter exited the distal end of the duodenoscope, it was observed that the needle was bent sideways. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. 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 50855107 ↗
• MalfunctionSep 17, 2026Deformation Due to Compressive Stress; Material Integrity Problem

  Note: This report pertains to one of two RX Needle Knife XL used in the same procedure.It was reported to Boston Scientific Corporation that an RX Needle Knife XL was used in the ampulla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat biliary stones performed on (b)(6) 2026.During the procedure, it was reported that the needle knife was bent and having an orientation problem. A second RX Needle Knife XL was used, and the needle knife was bent and the tip was damage. The procedure was completed with a third RX Needle Knife XL.There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798996 ↗
• MalfunctionSep 17, 2026Deformation Due to Compressive Stress; Positioning Problem

  Note: This report pertains to one of two RX Needle Knife XL used in the same procedure.It was reported to Boston Scientific Corporation that an RX Needle Knife XL was used in the ampulla during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat biliary stones performed on (b)(6) 2026.During the procedure, it was reported that the needle knife was bent and having an orientation problem. A second RX Needle Knife XL was used, and the needle knife was bent and the tip was damage. The procedure was completed with a third RX Needle Knife XL.There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798995 ↗
• MalfunctionSep 4, 2026Break

  It was reported to Boston Scientific Corporation that an RX Needle Knife XL was used in the common bile duct during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure to treat Cholelithiasis performed on (b)(6) 2026.During the procedure, it was reported that the cutting wire was broken. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601126 ↗
• MalfunctionMar 30, 2026Break; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE WAS FAULTY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE BROKE. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24733187 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS PREPARED CORRECTLY AND DID NOT SHOW ANY PROBLEM PRIOR TO BEING INSERTED INTO THE WORKING CHANNEL. UPON USE, HOWEVER, THE CUTTING WIRE BROKE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645108 ↗
• MalfunctionJan 30, 2026Break; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX NEEDLE KNIFE XL WAS ATTEMPTED TO BE USED IN THE DUCTUS CHOLEDOCHUS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. IT WAS REPORTED THAT PRIOR TO PROCEDURE, IT WAS NOTICED THAT THE NEEDLE WAS ALREADY EXTENDED IN THE PACKAGE AND IT COULD NOT BE RETRACTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CUTTING WIRE (NEEDLE) BROKEN/DETACHED/SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228906 ↗
• MalfunctionJan 6, 2026Deformation Due to Compressive Stress; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS ATTEMPTED TO BE USED IN THE PAPILLARY AREA DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN ORIENTATION ABNORMALITY IN THE CUTTING WIRE OF THE DEVICE OCCURRED. IT WAS ALSO REPORTED THAT THE CUTTING WIRE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX NEEDLE KNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985496 ↗
• InjuryNov 26, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE WAS USED ONCE WITH DIATHERMY AND THEN RE-SHEATHED. AN ATTEMPT TO USE THE DEVICE AGAIN WAS MADE AND UPON DEPLOYMENT, THE NEEDLE COMPLETELY DETACHED FROM THE INSTRUMENT AND FELL INTO THE MUCOSA. THE DETACHED PIECE WAS RETRIEVED WITHOUT CAUSING ANY HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662888 ↗
• MalfunctionNov 24, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX NEEDLE KNIFE XL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632173 ↗
• MalfunctionNov 14, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT GALL STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS THE SPHINCTEROTOME THROUGH THE PAPILLA. THE PHYSICIAN BEGAN TO PERFORM AN INFUNDIBULOTOMY BUT, THE NEEDLE KNIFE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX NEEDLE KNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551597 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TIP OF THE NEEDLE KNIFE BROKE OFF DURING CUTTING. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX NEEDLE KNIFE XL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551565 ↗
• MalfunctionNov 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AS THE NURSE OPENED THE DEVICE, THE NEEDLE WAS BENT. 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 23507043 ↗
• InjuryOct 23, 2025Device Slipped; Device Slipped

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO RX NEEDLE KNIFE XL USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX NEEDLE KNIFE X WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT AMPULLARY STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDE WIRE KEPT POPPING OUT OF THE RX CHANNEL OF THE CATHETER MAKING IT IMPOSSIBLE TO USE THE WIRE TO ADVANCE THE NEEDLE KNIFE PROPERLY. THE PHYSICIAN OPENED ANOTHER NEEDLE KNIFE BUT HAD THE SAME PROBLEM WITH THE DEVICE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THESE DEVICES; HOWEVER, THE PROCEDURE WAS ESTIMATED TO BE EXTENDED FOR AN EXTRA 45 MINUTES 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 23364461 ↗
• InjuryOct 23, 2025Device Slipped; Device Slipped

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO RX NEEDLE KNIFE XL USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX NEEDLE KNIFE X WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT AMPULLARY STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDE WIRE KEPT POPPING OUT OF THE RX CHANNEL OF THE CATHETER MAKING IT IMPOSSIBLE TO USE THE WIRE TO ADVANCE THE NEEDLE KNIFE PROPERLY. THE PHYSICIAN OPENED ANOTHER NEEDLE KNIFE BUT HAD THE SAME PROBLEM WITH THE DEVICE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THESE DEVICES; HOWEVER, THE PROCEDURE WAS ESTIMATED TO BE EXTENDED FOR AN EXTRA 45 MINUTES 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 23364437 ↗
• MalfunctionAug 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS RECEIVED BY THE CUSTOMER PRIOR TO AN ENDOSCOPY PROCEDURE TO BE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THERE WAS A MOISTURE INSIDE THE PACKAGING UPON ARRIVAL. THE PRODUCT WAS NOT USED IN THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790401 ↗
• MalfunctionJul 28, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX NEEDLE KNIFE XL WAS ATTEMPTED TO BE USED IN THE AMPULLA TO THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX NEEDLE KNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637849 ↗
• MalfunctionJun 27, 2025Mechanical Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX NEEDLE KNIFE XL WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLOTOMY PROCEDURE FOR THE TREATMENT OF CHOLANGITIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLADE DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349725 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE DID NOT WORK CORRECTLY. AFTER THE CATHETER WAS REMOVED FROM THE SCOPE, THE NEEDLE COULD NOT BE LOCATED WITHIN THE CATHETER. ACCORDING TO THE MEDICAL DOCTOR, FLUOROSCOPIC REVIEW CONFIRMED THAT NO NEEDLE REMAINED IN THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125888 ↗
• InjuryApr 4, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE NEEDLE KNIFE WAS INSIDE THE PATIENT AND THE PHYSICIAN WAS PERFORMING A CUT, AFTER THE FIRST CUT THE NEEDLE WAS BEND. THE PHYSICIAN THEN ASKS TO PUT THE NEEDLE BACK HOWEVER THE KNIFE SNAPPED AND FELL IN THE PATIENT'S AMPULLA. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO MOVE THE NEEDLE FRAGMENT AWAY FROM THE AMPULLA AND BELIEVED IT WAS DROPPED IN THE DUODENUM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21773620 ↗
• MalfunctionMar 26, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX NEEDLE KNIFE XL WAS PREPARED TO BE USE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION THE TECHNICIAN OPENS THE PACKAGING. IT WAS NOTED THAT THE NEEDLE KNIFE WOULD NOT EXTEND AND THE WIRE AT THE HANDLE OF THE DEVICE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698799 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX NEEDLE KNIFE XL WAS ATTEMPTED TO BE USED DURING A CUTTING OF A STRICTURE PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE KNIFE BROKE OFF DURING A CASE WHEN THE PHYSICIAN WAS CUTTING THROUGH A SCAR AND STRICTURE. IT WAS REPORTED THAT NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX NEEDLE KNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691722 ↗
• MalfunctionDec 11, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX NEEDLE KNIFE XL WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO CANNULATE THE AMPULLA AND ASKED FOR A NEEDLE KNIFE TO GAIN ACCESS. UPON GRABBING THE DEVICE, THE NURSE NOTICED A BEND IN THE CATHETER. ONCE THE DEVICE WAS OPENED, THE NURSE TRIED TO STRAIGHTEN OUT THE CATHETER AND ACTUATE THE HANDLE TO TEST TO MAKE SURE THE NEEDLE WOULD COME OUT THE END. WHEN THE HANDLE WAS SQUEEZED, A WIRE WAS NOTICED THAT CAME OUT OF THE HANDLE ARE. IT WAS REPORTED THAT THE PULL WIRE WAS BROKEN AND EXPOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX NEEDLE KNIFE XL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907723 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES MENTIONED IN THE LITERATURE ARTICLE. REFER TO MANUFACTURER REPORTS # 3005099803-2024-05813 AND 3005099803-2024-05814 FOR THE ASSOCIATED DEVICE INFORMATION. BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING ULTRATOME XL SPHINCTEROTOMES, FLUORO TIP ERCP CATHETERS, AND NEEDLE KNIFE PAPILLOTOMES, THROUGH THE ARTICLE, USEFULNESS AND COMPLICATIONS OF NEEDLE KNIFE FISTULOTOMY AS A RESCUE PROCEDURE IN PATIENTS WITH PANCREATICOBILIARY DISEASE, BY YONG JAE LEE, ET AL. PER THE ARTICLE, BETWEEN JANUARY 2009 AND DECEMBER 2016, PATIENTS UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, AND THE FOLLOWING OCCURRED: MILD AND MODERATE PANCREATITIS, BLEEDING AND HYPERAMYLASEMIA. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pancreatitis

  MAUDE report 20679955 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES MENTIONED IN THE LITERATURE ARTICLE. REFER TO MANUFACTURER REPORTS # 3005099803-2024-05666, 3005099803-2024-05668, 3005099803-2024-05669, 3005099803-2024-05804 AND 3005099803-2024-05805 FOR THE ASSOCIATED DEVICE INFORMATION. BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING JAGWIRE GUIDEWIRES, AUTOTOME RX SPHINCTEROTOMES, PULL TYPE SPHINCTEROTOMES, MICROKNIFE NEEDLE KNIFE PAPILLOTOMES, AND RX LOCKING DEVICES THROUGH THE ARTICLE, COMPARISON OF PHYSICIAN-CONTROLLED MANEUVER AND ASSISTANT-CONTROLLED MANEUVER DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, BY MIN JE SUNG, ET AL. PER THE ARTICLE, BETWEEN (B)(6) 2015 AND (B)(6) 2016, PATIENTS UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN WHICH PHYSICIAN-CONTROLLED WIRE-GUIDED CANNULATION (PCWGC) AND/OR ASSISTANT-CONTROLLED WIRE-GUIDED CANNULATION (ACWGC) CANNULATION TECHNIQUES WERE USED. IN CASES WHERE PCWGC WAS UTILIZED, THE FOLLOWING OCCURRED: PANCREATITIS, BLEEDING, PERFORATION, CHOLANGITIS. IN CASES WHERE ACWGC WAS UTILIZED, THE FOLLOWING OCCURRED: PANCREATITIS, BLEEDING, PERFORATION. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

  Patient problems: Cholangitis; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation

  MAUDE report 20670852 ↗