SpyScope DS M00546600Recalls & reported problems

Summary

The FDA's MAUDE database contains 912 adverse event reports that list this exact device (DI 08714729863236), received between Nov 13, 2016 and Aug 21, 2024 — classified as 10 injuries, 902 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (883 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 912 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS & DELIVERY CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF BILE DUCT STONES IN THE BILE DUCT ON (B)(6) 2024. DURING THE PROCEDURE, THE CATHETER COULD NOT BE RECOGNIZED AFTER IT WAS CONNECTED TO THE CONSOLE. 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 20014870 ↗
• MalfunctionMay 31, 2023Poor Quality Image; Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO SPYSCOPE DS ACCESS & DELIVERY CATHETER AND SPYGLASS DIGITAL CONTROLLER THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPYSCOPE DS ACCESS & DELIVERY CATHETER AND SPYGLASS DIGITAL CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON MAY 09, 2023. DURING THE PROCEDURE, THE DEVICE COULD NOT SHOW IMAGE CLEARLY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17034932 ↗
• MalfunctionMar 21, 2023Optical Problem; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SPYSCOPE DS WOULD NOT EMIT LIGHT. THE PROCEDURE WAS NOT COMPLETED BASED UPON 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 16582861 ↗
• MalfunctionDec 6, 2022Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS WAS USED DURING AN INTRAHEPATIC BILE DUCT PROBING PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, THE SPYSCOPE DS SCREEN FLICKERED SEVERELY AND COULD NO LONGER USED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924017 ↗
• MalfunctionDec 28, 2021Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER WAS USED IN THE COMMON BILE DUCT DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SCOPE DID NOT CONNECT TO THE CONTROLLER PROPERLY. THE IMAGE WAS LOST APPROXIMATELY ONE HOUR DURING THE PROCEDURE. THE SPYSCOPE WAS UNPLUGGED AND PLUGGED BACK INTO THE CONTROLLER; EVENTUALLY, THEY COULD NOT GET THE IMAGE TO DISPLAY. THE PROCEDURE WAS RESCHEDULED AND WAS COMPLETED WITH A SPYSCOPE DS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094209 ↗
• MalfunctionDec 3, 2021Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS CATHETER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2021. DURING THE PROCEDURE, THE IMAGE OF THE SPYSCOPE DS WAS LOST A FEW MINUTES INTO THE PROCEDURE DURING FLUROSCOPY SHOTS. THE PHYSICIAN DECIDED NOT TO FIRE THE ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROBE AND TURNED OFF THE CONTROLLER. AFTER A FEW MINUTES, THE CONTROLLER WAS TURNED BACK ON AND A GRAY IMAGE WITH THREE DOTS APPEARED ON THE SCREEN. THE PROCEDURE WAS RESCHEDULED TO PERFORM THE LITHOTRIPSY IN A FUTURE SESSION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924397 ↗
• MalfunctionJan 27, 2021Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS WAS USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, NO IMAGE APPEARS ON THE SCREEN AFTER CONNECTING THE SPYSCOPE DS AND SWITCHING ON THE CONTROLLER.THE PROCEDURE WAS RE-SCHEDULED FOR NEXT WEEK DUE TO SCOPE UNAVAILABILITY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11237365 ↗
• MalfunctionDec 1, 2020Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS AND SPYGLASS DS CONTROLLER WERE USED DURING A PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE DS DID NOT SHOW AN IMAGE. THE PROCEDURE WAS NOT COMPLETED 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. THE DEVICE WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10927049 ↗
• MalfunctionOct 9, 2020Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO A SPYGLASS DS CONTROLLER AND TWO SPYSCOPE DS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DS CONTROLLER AND TWO SPYSCOPE DS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN NOTICED THAT THE FIRST SPYSCOPE DS FREQUENTLY APPEARED BLACK SCREEN AND COULD NOT SHOW THE IMAGE BEFORE THE PROCEDURE. A SECOND SPYSCOPE DS WAS USED, HOWEVER, THE PROBLEM STILL OCCURRED. THE PROCEDURE WAS NOT COMPLETED 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. ***ADDITIONAL INFORMATION (B)(6) 2020*** REPORTEDLY, THE TWO SPYSCOPE DS II HAVE BEEN USED WITH A DIFFERENT SPYGLASS DS CONTROLLER AND WORKED AS INTENDED SINCE THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655642 ↗
• MalfunctionOct 9, 2020Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO A SPYGLASS DS CONTROLLER AND TWO SPYSCOPE DS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DS CONTROLLER AND TWO SPYSCOPE DS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE PHYSICIAN NOTICED THAT THE FIRST SPYSCOPE DS FREQUENTLY APPEARED BLACK SCREEN AND COULD NOT SHOW THE IMAGE BEFORE THE PROCEDURE. A SECOND SPYSCOPE DS WAS USED, HOWEVER, THE PROBLEM STILL OCCURRED. THE PROCEDURE WAS NOT COMPLETED 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. ***ADDITIONAL INFORMATION (B)(6) 2020*** REPORTEDLY, THE TWO SPYSCOPE DS II HAVE BEEN USED WITH A DIFFERENT SPYGLASS DS CONTROLLER AND WORKED AS INTENDED SINCE THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655640 ↗
• MalfunctionSep 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS WAS USED DURING A CHOLANGIOSCOPY PROCEDURE IN THE COMMON BILE DUCT (CBD) PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE DISTAL TIP OF THE SPYSCOPE DS DETACHED. REPORTEDLY, THE DETACHED PART WAS SUCCESSFULLY RETRIEVED USING A STONE EXTRACTION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10504481 ↗
• MalfunctionAug 27, 2020Difficult to Advance; Appropriate Device Problem Term/Code Not Available; Difficult to Advance; Appropriate Device Problem Term/Code Not Available

  THIS REPORT PERTAINS TO THE SECOND OF TWO SPYSCOPE DS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE AMPULLA AND BILE DUCT ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS INTO THE BILE DUCT WITH A GUIDEWIRE AND TOME. THE FIRST SPYSCOPE DS WAS BACKLOADED OVER THE GUIDEWIRE AND HAD ACCESS INTO THE BILE DUCT; HOWEVER, THE IMAGE NEVER APPEARED ON THE SCREEN. A SECOND SPYSCOPE DS WAS USED BUT THEY COULD NOT ADVANCE IT INTO THE BILE DUCT. SO, THE PHYSICIAN GAVE UP ATTEMPTING AND THE SPY PORTION OF THE PROCEDURE WAS RESCHEDULED FOR APPROXIMATELY TWO MONTHS FROM (B)(6), 2020. THE OVERALL ERCP PROCEDURE WAS COMPLETED WITH A NON-BSC CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462671 ↗
• MalfunctionAug 27, 2020Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO SPYSCOPE DS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE AMPULLA AND BILE DUCT ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS INTO THE BILE DUCT WITH A GUIDEWIRE AND TOME. THE FIRST SPYSCOPE DS WAS BACKLOADED OVER THE GUIDEWIRE AND HAD ACCESS INTO THE BILE DUCT; HOWEVER, THE IMAGE NEVER APPEARED ON THE SCREEN. A SECOND SPYSCOPE DS WAS USED BUT THEY COULD NOT ADVANCE IT INTO THE BILE DUCT. SO, THE PHYSICIAN GAVE UP ATTEMPTING AND THE SPY PORTION OF THE PROCEDURE WAS RESCHEDULED FOR APPROXIMATELY TWO MONTHS FROM (B)(6) 2020. THE OVERALL ERCP PROCEDURE WAS COMPLETED WITH A NON-BSC CYTOLOGY BRUSH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462649 ↗
• MalfunctionAug 17, 2020Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  THIS REPORT PERTAINS TO A SPYSCOPE DS AND SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS AND SPYGLASS DS CONTROLLER WERE USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED IN THE BILIARY DUCT ON (B)(4) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE IMAGE OF THE SPYSCOPE DS WAS LOST APPROXIMATELY 5 MINUTES INTO THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10416024 ↗
• MalfunctionJul 28, 2020Poor Quality Image; Difficult to Advance; Optical Problem; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Difficult to Advance; Optical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II AND A SPYSCOPE DS THAT WERE USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II AND A SPYSCOPE DS WERE USED IN THE PANCREATIC DUCT DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE DS II WAS INSERTED INTO THE WORKING CHANNEL OVER A TERUMO GUIDEWIRE AND THE PHYSICIAN WAS ABLE TO INTUBATE THE PAPILLA; HOWEVER, THE IMAGE WAS LOST 1 MINUTE AFTER INSERTION. THE CONTROLLER WAS RESTARTED AND THE SCOPE WAS RECONNECTED; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE SPYSCOPE DS II WAS REMOVED AND THE PHYSICIAN CHANGED TO A SPYSCOPE DS. THE PHYSICIAN INTUBATED THE PAPILLA AND PANCREATIC DUCT OVER THE GUIDEWIRE AND PLACED THE SPYSCOPE DS IN FRONT OF THE STONE. THE PHYSICIAN WITHDREW THE GUIDEWIRE AND INSERTED THE SPYBASKET; HOWEVER, THE PHYSICIAN WAS HAVING DIFFICULTY ADVANCING THE SPYBASKET TO THE TIP OF THE SPYSCOPE DS. WHILE STRAIGHTENING THE SPYSCOPE DS THE IMAGE DISPLAYED MULTIPLE COLORED STRIPES AND THE IMAGE WAS LOST APPROXIMATELY 3 MINUTES INTO THE PROCEDURE. THE CONTROLLER WAS RESTARTED SEVERAL TIMES BUT THE ISSUE WAS N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10332524 ↗
• MalfunctionJun 24, 2020Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS AND SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS AND SPYGLASS DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE BILIARY ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE AND POST SEDATION, THE PHYSICIAN NOTICED THAT THE SPYSCOPE DS AND THE SPYGLASS DS CONTROLLER DID NOT PROVIDE ANY IMAGE. THERE WAS NO DIAGNOSTIC IMAGE OR OVERLAY VISIBLE. THE PROCEDURE WAS NOT COMPLETED 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 OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10191084 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS WAS USED IN THE LIVER AND PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THERE WERE NO ISSUES NOTED WITH THE SPYSCOPE DS DURING THE PROCEDURE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT DEVELOPED A FISTULA IN THE LIVER. ON AN UNKNOWN DATE, THE PATIENT WENT BACK TO THE HOSPITAL FOR PLACEMENT OF PERCUTANEOUS DRAINAGE; SUBSEQUENTLY, THE DRAINAGE WAS REMOVED AND PATIENT WAS DISCHARGED. ON AN UNKNOWN DATE, THE PATIENT CAME BACK TO HOSPITAL FOR A POLYP PROCEDURE IN WHICH A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED. POST STENT PLACEMENT, THE PATIENT HAD CHOLECYSTITIS AND WAS HOSPITALIZED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY FOR THE PANCREATIC MASS. PER THE PHYSICIAN, THE PATIENT HAD A BAD PANCREATIC CANCER. THE PATIENT'S CONDITION FOLLOWING THE SURGERY WAS REPORTED TO BE STABLE. NOTE: DESPITE EFFORTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPL

  Patient problems: Fistula; Inflammation

  MAUDE report 9694814 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019 AS PART OF THE (B)(6) STUDY. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD NO SIGNIFICANT MEDICAL HISTORY REPORTED. AS PART OF THE PATIENT'S ASSESSMENT, ENDOSCOPIC ULTRASOUND (EUS) WAS PERFORMED WITH VISIBILITY OF 3 STONES, AND THE BILE DUCT DIAMETER ON IMAGING WAS MEASURED TO BE 5.1 MM. AS THE PATIENT UNDERWENT THE STUDY PROCEDURE, HE WAS GIVEN PROPHYLACTIC ANTIBIOTICS AS WELL AS INDOMETHACIN. DURING THE PROCEDURE, A SPHINCTEROTOME WAS ALSO USED AND THE IMAGING OF THE SPYSCOPE DS WAS RATED AS EXCELLENT. FOUR BILIARY STONES WERE SEEN DURING CHOLANGIOSCOPY AND ALL FOUR BILIARY STONES WERE REMOVED. ON (B)(6) 2019, THE PATIENT HAD POST-ERCP PANCREATITIS WITH MODERATE SEVERITY. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2019 AS A RESULT OF THE PANCREATITIS. THE PHYSICIAN BELIEVES THAT THERE WAS A POSSIBLE RELATIONSHIP BETWEEN THE ERCP PROCEDURE AND THE PANCREATITIS. ADDITIONALLY, THE PHYSICIAN BELIEVES THAT THERE WAS A POSSIBLE RELATIONSHIP BETWEEN THE SPYSCOPE DS

  Patient problems: Inflammation

  MAUDE report 8934848 ↗
• MalfunctionMay 17, 2019Material Protrusion/Extrusion; Optical Problem; Material Protrusion/Extrusion; Optical Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE LEFT HEPATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY WERE ABLE TO START THE PROCEDURE WITH THE SPYSCOPE DS FUNCTIONING WELL. HALFWAY THROUGH THE PROCEDURE, THE DEVICE JUST STOPPED WORKING AND VISUALIZATION WAS LOST. THEY TRIED TO RESTART THE CONTROLLER AND RECONNECTED THE SPYSCOPE DS; HOWEVER, IT STILL DID NOT WORK. REPORTEDLY, IT WAS ALSO NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. 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 AND GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619543 ↗
• MalfunctionMay 9, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. 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 Consequences Or Impact To Patient

  MAUDE report 8594817 ↗
• MalfunctionMay 8, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. 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 Consequences Or Impact To Patient

  MAUDE report 8590523 ↗
• MalfunctionMay 1, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILE DUCT DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSCOPE DS WAS INSERTED INTO THE BILE DUCT VIA A GUIDEWIRE. THEY WERE ABLE TO PUSH THE DEVICE TO THE STENOSIS WITHOUT RESISTANCE. WHEN THE GUIDEWIRE WAS REMOVED, THE PHYSICIAN NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. THE SPYSCOPE DS WAS REMOVED AND REPLACED WITH A NEW ONE. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL GUIDEWIRE AND THE SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. 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 Consequences Or Impact To Patient

  MAUDE report 8570771 ↗
• MalfunctionMay 1, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE END OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569181 ↗
• MalfunctionApr 30, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILIARY SYSTEM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, SPYBITE BIOPSY FORCEPS WAS INSERTED THROUGH THE SPYSCOPE DS AND SEVERAL BIOPSIES WERE PERFORMED. IT WAS THEN FOUND THAT THE FORCEPS WOULD NOT OPEN PROPERLY TOWARDS THE END OF THE PROCEDURE AND THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED THE PROCEDURE WAS STILL COMPLETED USING THE SAME ORIGINAL SPYBITE BIOPSY FORCEPS AND SPYSCOPE DS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566833 ↗
• MalfunctionApr 24, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ADVANCING THE SPYBITE BIOPSY FORCEPS THROUGH THE SPYSCOPE DS, IT WAS NOTICED THAT THE WORKING CHANNEL SLEEVE OF THE SPYSCOPE DS PROTRUDED. THERE WERE NO ISSUES REPORTED WITH THE SPYBITE BIOPSY FORCEPS. THE PROCEDURE WAS STILL COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546988 ↗