SpyGlass™ Retrieval Snare M00546560Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729965893), received between Nov 21, 2018 and Dec 19, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL SNARE WAS USED IN THE BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS DURING A CHOLEDOSCOPY WITH LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE HAD RESISTANCE WHEN OPENING. IT WAS HARD TO REMOVE THE STENT FROM THE PATIENT AND THE SNARE LOOP STRANDS BROKE. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355698 ↗
• InjuryApr 6, 2023Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL SNARE WAS USED DURING A METALLIC STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A SPYSNARE LOOP WIRE BROKE INSIDE THE PATIENT WHILE TRYING TO RETRIEVE A METALLIC STENT. THE LOOP WIRE WAS RETRIEVED WITH FORCEPS AND A PLASTIC STENT WAS IMPLANTED SINCE THE METALLIC STENT COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693645 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL SNARE WAS USED FOR PROXIMAL MIGRATED STENT REMOVAL IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) - CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPYSNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15631318 ↗
• MalfunctionApr 8, 2021Mechanical Problem; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO THE TWO SPYSCOPE DS II, SPYSNARE AND SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO SPYSCOPE DS II, SPYSNARE AND SPYGLASS DS CONTROLLER WERE USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2021. DURING THE PROCEDURE, THE IMAGE OF THE FIRST SPYSCOPE DS II WAS LOST LESS THAN 5 MINUTES INTO THE PROCEDURE. A SECOND SPYSCOPE DS II WAS USED, HOWEVER, THE IMAGE WAS ALSO LOST. AN AUTOLITH ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROBE WAS USED WHEN THE VISUALIZATION PROBLEMS OCCURRED. THE SPYSCOPE DS II WAS DISCONNECTED AND RECONNECTED BACK TO THE CONTROLLER, AND THE CONTROLLER WAS REBOOTED SEVERAL TIMES; HOWEVER, THE PROBLEM WAS NOT RESOLVED. THEY ALSO TRIED TO USED A SPYSNARE, AND IT FAILED TO OPEN WHEN IT WAS INSIDE THE SCOPE AND INSIDE THE PATIENT. THE PROCEDURE WAS RESCHEDULED 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 11633975 ↗
• InjuryMar 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL SNARE WAS USED IN THE MIDDLE AND UPPER BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYSNARE WAS INTRODUCED TO REMOVE A NON-BSC MIGRATED PLASTIC STENT. REPORTEDLY, THE DISTAL END OF THE SPYSNARE DETACHED WHEN IT WAS PULLED OUT WITH THE MIGRATED PLASTIC STENT. REPORTEDLY, THE ENTIRE SPYSNARE (INCLUDING THE SNARE END) WAS REMOVED FROM THE PATIENT. THE PLASTIC STENT WAS SUCCESSFULLY RETRIEVED USING A NON-BSC POLYPECTOMY HANDLE 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842579 ↗
• InjuryNov 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL SNARE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TWO SPYSNARES BROKE WHILE TRYING TO RETRIEVE A PLASTIC STENT. ONE OF THE SPYSNARES HAD THE LOOP WIRE BREAK INSIDE THE PATIENT. THE LOOP WIRE WAS RETRIEVED WITH A FORCEP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8094167 ↗