Jagwire M00556580Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08714729747215), received between Jan 13, 2017 and Sep 11, 2026 — classified as 1 death, 5 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744400 ↗
• MalfunctionJul 17, 2026Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25851565 ↗
• MalfunctionJul 9, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED IN THE COLON DURING A COLON STENT PLACEMENT PROCEDURE TO TREAT COLORECTAL CANCER PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DISTAL TIP WAS SEPARATED AND REMAINED IN THE BODY. IT WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS DISCONTINUED AND EVENTUALLY CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25771548 ↗
• MalfunctionApr 1, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS RECEIVED BY THE CUSTOMER ON (B)(6) 2026. IT WAS REPORTED THAT A PERFORATION WAS REPORTED ON THE PRODUCT PACKAGING, CAUSING THE CONTENTS TO BECOME VISIBLE. THE DEVICE WAS NOT USED IN A PROCEDURE. THE REPORTED EVENT MAY SUGGEST THAT THE STERILE BARRIER WAS COMPROMISED DUE TO THE DAMAGED PACKAGING. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760559 ↗
• MalfunctionFeb 3, 2026Nonstandard Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE JAGWIRE WAS REPORTED AS DEFECTIVE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS REPORTED THAT THE PATIENT HOSPITALIZATION WAS PROLONGED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248822 ↗
• MalfunctionJan 12, 2026Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR JAGWIRES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ADVANCING THE GUIDEWIRE INTO THE COMMON BILE DUCT, PEELING OCCURRED ON THE BLACK PART OF THE HYDROPHILIC TIP. THE SAME PROBLEM OCCURRED WITH THE OTHER THREE JAGWIRES. DUE TO THIS PROBLEM, THE PROCEDURE HAD TO BE TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049823 ↗
• MalfunctionJan 12, 2026Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR JAGWIRES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ADVANCING THE GUIDEWIRE INTO THE COMMON BILE DUCT, PEELING OCCURRED ON THE BLACK PART OF THE HYDROPHILIC TIP. THE SAME PROBLEM OCCURRED WITH THE OTHER THREE JAGWIRES. DUE TO THIS PROBLEM, THE PROCEDURE HAD TO BE TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049647 ↗
• MalfunctionJan 12, 2026Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR JAGWIRES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ADVANCING THE GUIDEWIRE INTO THE COMMON BILE DUCT, PEELING OCCURRED ON THE BLACK PART OF THE HYDROPHILIC TIP. THE SAME PROBLEM OCCURRED WITH THE OTHER THREE JAGWIRES. DUE TO THIS PROBLEM, THE PROCEDURE HAD TO BE TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049627 ↗
• MalfunctionJan 12, 2026Peeled/Delaminated

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR JAGWIRES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ADVANCING THE GUIDEWIRE INTO THE COMMON BILE DUCT, PEELING OCCURRED ON THE BLACK PART OF THE HYDROPHILIC TIP. THE SAME PROBLEM OCCURRED WITH THE OTHER THREE JAGWIRES. DUE TO THIS PROBLEM, THE PROCEDURE HAD TO BE TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049515 ↗
• InjuryJun 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDEWIRE EXPERIENCED AN UNANTICIPATED DISTAL FRACTURE INTO SEVERAL SEGMENTS, AS IT WAS EMERGING FROM THE TIP OF THE SCOPE AND PRIOR TO ENTERING THE COMMON BILE DUCT. ALSO, IT WAS NOTED THAT THE DISTAL TIP DETACHED. IT WAS REPORTED THAT THE GUIDEWIRE WAS RETRIEVED IN TWO STAGES. FIRST AS AN INTACT UNIT FOLLOWED BY REMOVAL OF THE FRACTURED SEGMENTS BY BIOPSY GRASPING FORCEPS. 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 AND 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 22346865 ↗
• InjuryJun 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDEWIRE EXPERIENCED AN UNANTICIPATED DISTAL FRACTURE INTO SEVERAL SEGMENTS, AS IT WAS EMERGING FROM THE TIP OF THE SCOPE AND PRIOR TO ENTERING THE COMMON BILE DUCT. ALSO, IT WAS NOTED THAT THE DISTAL TIP DETACHED. IT WAS REPORTED THAT THE GUIDEWIRE WAS RETRIEVED IN TWO STAGES. FIRST AS AN INTACT UNIT FOLLOWED BY REMOVAL OF THE FRACTURED SEGMENTS BY BIOPSY GRASPING FORCEPS. 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 AND 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 22346834 ↗
• MalfunctionApr 30, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS BEING PREPARED FOR USE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE HYDROPHILIC COATING OF THE GUIDEWIRE HAD COME OFF. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY BECAUSE THEY DID NOT HAVE MORE MATERIAL. 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 21936457 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO JAGWIRES THAT WERE USED IN THE RETROSPECTIVE STUDY. BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING CAPTIVATOR II SNARES, INTERJECT NEEDLES, JAGWIRES AND RESOLUTION CLIPS THROUGH THE ARTICLE "THE USEFULNESS OF TRACTION-ASSISTED ENDOSCOPIC PAPILLECTOMY FOR AMPULLARY EARLY TUMORS" BY XIE JIAO ET AL. PER ARTICLE, BETWEEN JANUARY 2010 AND AUGUST 2022, STUDY OF 173 PATIENTS SUFFERING AMPULLARY TUMORS UNDERWENT ENDOSCOPIC PAPILLECTOMY PROCEDURES. TWO TECHNIQUES WERE USED: TRACTION ASSISTED, AND NON-TRACTION ASSISTED METHODS. THE FOLLOWING OCCURRED WITH THE STUDY PATIENTS: PANCREATITIS, CHOLANGITIS, PERFORATIONS, INTRAOPERATIVE BLEEDING THAT REQUIRED ENDOSCOPIC HEMOSTASIS AND BLOOD TRANSFUSION. PLEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS.

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

  MAUDE report 21035624 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED IN THE PANCREATIC DUCT (PD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CORE/INNER PART OF THE JAGWIRE WAS STRIPPED OFF AND REMAINED IN THE PD. THE PROCEDURE WAS COMPLETED WITH THE SAME JAGWIRE 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 FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226847 ↗
• MalfunctionDec 14, 2022Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6) 2022. DURING PREPARATION, THE GUIDEWIRE PEELED OFF. THE PHYSICIAN REPLACED IT WITH A SECOND JAGWIRE GUIDEWIRE, BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE THIRD JAGWIRE GUIDEWIRE. 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 CORE WIRE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15979998 ↗
• MalfunctionDec 8, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC ULTRASOUND PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, THE PTFE COATING PEELED OFF WHILE REMOVING THE GUIDEWIRE FROM THE SCOPE. THE COATING WAS NOT REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940994 ↗
• MalfunctionSep 14, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING INTERVENTIONAL PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE GUIDEWIRE PEELED OFF. THE PROCEDURE WAS NOT COMPLETED 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 15422044 ↗
• MalfunctionMar 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE AS BEING USED IN COMMON BILE DUCT DURING ERCP AND REMOVAL OF STONES PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN USED A STONE RETRIEVAL EXACTOR BALLOON IN THE COMMON BILE DUCT OVER THE GUIDEWIRE. AT THE TIME OF RETRACTION OF THE GUIDEWIRE, THE PHYSICIAN NOTICED A SMALL FRAGMENT ON THE X-RAY. THEY PULLED OUT THE GUIDEWIRE AND SAW THAT A PART OF IT WAS PEELED OFF. IT WAS REPORTED THAT THE COATING ON THE TIP WAS NOT ACTIVATED USING SALINE BEFORE INSERTING. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929156 ↗
• MalfunctionFeb 4, 2022Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED IN THE COMMON BILE DUCT DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY) PROCEDURE ON (B)(6) 2021. DURING PREPARATION, THE NURSE NOTICED THAT THE GUIDEWIRE TIP WAS PEELED. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453718 ↗
• MalfunctionMar 29, 2021Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED IN THE BILIARY TRACT DURING A PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE COULD NOT CROSS THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A NEW JAGWIRE GUIDEWIRE. 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 STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE BREAK OR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585537 ↗
• DeathJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE AND EXTRACTOR PRO WERE USED IN THE COLON DURING A WALLFLEX COLONIC METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN INITIALLY USED AN EGD SCOPE TO CHECK THE TUMOR/STRICTURE, THEN USED A JAGWIRE AND EXTRACTOR PRO THROUGH AN ADULT COLONOSCOPE TO GAIN ACCESS THROUGH THE STRICTURE. THE BALLOON WAS ADVANCED DOWN THE GUIDEWIRE AND ENTERED THE BIOPSY CHANNEL OF THE SCOPE HOWEVER IT DID NOT EXIT THE DISTAL TIP. ACCESS WAS LOST AND THE GUIDEWIRE SLIPPED OUT OF THE STRICTURE. AT THIS POINT, ONLY THE GUIDEWIRE WAS IN THE COLONOSCOPE. A PERFORATION OCCURRED WHEN THE PHYSICIAN REPOSITIONED THE SCOPE NEAR THE TUMOR. IT IS UNKNOWN WHAT CAUSED THE PERFORATION. AT THAT POINT THE PATIENT WAS SENT TO SURGERY. THE PATIENT DIED, HOWEVER, IT IS UNKNOWN IF IT HAPPENED DURING OR AFTER THE SURGERY. THERE IS NO INFORMATION REGARDING THE CAUSE OF THE PATIENT'S DEATH, AND AUTOPSY RESULTS WERE NOT MADE AVAILABLE. REPORTEDLY, THE PATIENT HAD A MALIGNANT TUMOR IN THE COLON, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Death; Perforation

  MAUDE report 11158301 ↗
• MalfunctionNov 10, 2020Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT JAGWIRE GUIDEWIRE WAS USED IN THE BILIARY SYSTEM (PAPILLA) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PAPILLA WAS CUT WITH A SPHINCTEROTOME AND GUIDEWIRE WAS INSERTED IN THE NON BOSTON SCIENTIFIC DUODENOSCOPE, THE PTFE PEELED. THIS HAPPENED WITH SEVEN JAGWIRES. THE PROCEDURE WAS CANCELLED BASED UPON NO ADDITIONAL STOCK AVAILABLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817095 ↗
• MalfunctionNov 10, 2020Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT JAGWIRE GUIDEWIRE WAS USED IN THE BILIARY SYSTEM (PAPILLA) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PAPILLA WAS CUT WITH A SPHINCTEROTOME AND GUIDEWIRE WAS INSERTED IN THE NON BOSTON SCIENTIFIC DUODENOSCOPE, THE PTFE PEELED. THIS HAPPENED WITH SEVEN JAGWIRES. THE PROCEDURE WAS CANCELLED BASED UPON NO ADDITIONAL STOCK AVAILABLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10816991 ↗
• MalfunctionNov 10, 2020Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT JAGWIRE GUIDEWIRE WAS USED IN THE BILIARY SYSTEM (PAPILLA) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PAPILLA WAS CUT WITH A SPHINCTEROTOME AND GUIDEWIRE WAS INSERTED IN THE NON BOSTON SCIENTIFIC DUODENOSCOPE, THE PTFE PEELED. THIS HAPPENED WITH SEVEN JAGWIRES. THE PROCEDURE WAS CANCELLED BASED UPON NO ADDITIONAL STOCK AVAILABLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10816919 ↗
• MalfunctionNov 10, 2020Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT JAGWIRE GUIDEWIRE WAS USED IN THE BILIARY SYSTEM (PAPILLA) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PAPILLA WAS CUT WITH A SPHINCTEROTOME AND GUIDEWIRE WAS INSERTED IN THE NON BOSTON SCIENTIFIC DUODENOSCOPE, THE PTFE PEELED. THIS HAPPENED WITH SEVEN JAGWIRES. THE PROCEDURE WAS CANCELLED BASED UPON NO ADDITIONAL STOCK AVAILABLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10816918 ↗