SpyGlass™ Retrieval Basket M00546550Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729965886), received between Oct 2, 2018 and Sep 11, 2025 — classified as 13 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BASKET WAS FRACTURED AT ITS MIDSECTION AND DISLODGED INTO THE DUODENUM. A FOREIGN BODY FORCEPS WAS USED TO RETRIEVED THE FRACTURED BASKET. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025308 ↗
• InjurySep 5, 2025Break; Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A SPYGLASS RETRIEVAL BASKET CAPTURED A BILIARY STONE. HOWEVER, THE BASKET AND SPYGLASS SCOPE WAS UNABLE TO BE WITHDRAW FROM THE DUCT. THE ASSISTING TECHNICIAN ATTEMPTED TO CRUSH OR REDUCED THE SIZE OF THE STONE. AS A RESULT, THE BASKET DETACHED FROM THE DEVICE AND THE BASKET WIRES BROKE. THE HANDLE AND CATHETER OF THE SPYGLASS BASKET WAS REMOVED FROM THE SPYGLASS SCOPE, BUT THE BASKET PORTION AND STONE REMAINED STUCK INSIDE THE DUCT. PHYSICIAN SPENT APPROXIMATELY 3 HOURS ATTEMPTING TO RESOLVE THE ISSUE, AND WAS FINALLY SUCCESSFUL USING AN ELECTROHYDRAULIC LITHOTRIPSY (EHL) TO FRAGMENT THE STONE. BIOPSY FORCEPS WAS THEN USED TO RETRIEVE THE BASKET, AND A TRAPEZOID BASKET TO REMOVE REMAINING COMPONENTS OF THE BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. PLEASE NOTE THAT AS PER THE INSTRUCTIONS FOR USE (IFU) OF THE SPYGLASS RETRIEVAL BASKET, THE SPYGLASS RETRIEVAL BASKET IS INDICATED FOR ENDOSCOPIC REMOVAL OF STONES, STONE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983842 ↗
• MalfunctionAug 22, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN PANCREATIC DUCT DURING A CHOLANGIOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PATIENT WAS SEDATED, AND THE SPYBASKET WAS INSERTED INTO THE WORKING CHANNEL BUT COULD NOT BE ADVANCED. THE SCOPE WAS REMOVED FROM THE PANCREATIC DUCT, AND IT WAS IMPOSSIBLE TO RETRIEVE THE BASKET. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED DUE TO THE PROLONGED EXAMINATION TIME. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22871825 ↗
• MalfunctionJun 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 SPYGLASS RETRIEVAL BASKET WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE WIRE GOT DISCONNECTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON JUNE 8, 2025*** IT WAS THE BASKET WIRES THAT GOT DISCONNECTED BUT STILL ATTACHED TO THE DEVICE. THE PROBLEM OCCURRED DURING PROCEDURE INSIDE THE PATIENT. THE ANATOMY WAS THE COMMON BILE DUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157341 ↗
• InjuryAug 12, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE HANDLE OF THE SPYBASKET STOPPED WORKING AS THE STONE WAS BEING EXTRACTED. THE BASKET WOULD NOT OPEN OR CLOSE ANYMORE, AND THE STONE GOT TRAPPED IN THE DISTAL COMMON BILE DUCT. A RESCUE HANDLE WAS USED TO BREAK THE BASKET. A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON AUGUST 15, 2024.*** THE RESCUE HANDLE USED WAS A SOEHENDRA HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967853 ↗
• InjuryJul 25, 2024Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, TWO AUTOLITH ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROBES WERE USED TO ATTEMPT TO CRUSH A STONE APPROXIMATELY 4-5 CM IN SIZE BUT WAS UNSUCCESSFUL. A SPYGLASS RETRIEVAL BASKET WAS THEN USED; HOWEVER, THE BASKET WAS UNABLE TO CRUSH THE STONE AND BECAME EMBEDDED IN THE BASKET. MULTIPLE ATTEMPTS WERE MADE WITH DIFFERENT DEVICES TO REMOVE THE STONE BUT FAILED. THE PROCEDURE WAS ABORTED DUE TO CONCERN FOR BILE DUCT INJURY AND LENGTH OF PROCEDURE TIME. THE BASKET WIRE WAS CUT AT THE PATIENT'S MOUTH AND THE BASKET WITH THE STONE REMAINED INSIDE THE DUCT. THE PATIENT WAS HOSPITALIZED AND SCHEDULED FOR ANOTHER PROCEDURE TO REMOVE THE STONE AND BASKET. ON (B)(6) 2024, THE PATIENT WAS SENT FOR ANOTHER ERCP. SPY AND EHL WERE USED TO REMOVE THE BASKET AND STONE FROM THE BILE DUCT WITHOUT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19834466 ↗
• InjuryJul 18, 2024Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A SPYBASKET WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2024. DURING THE PROCEDURE, THE BASKET WAS ADVANCED OVER A 7 MM STONE AND CLOSED. THE BASKET GOT STUCK AND WAS NOT ABLE TO BE REMOVED FROM THE DUCT. THE BASKET WAS LEFT INSIDE THE PATIENT AND THE CATHETER WAS REMOVED DURING ATTEMPTS TO DISLODGE. THEY TRIED USING ELECTROHYDRAULIC LITHOTRIPSY (EHL), BRUSH, RETRIEVAL SNARE, AND MECHANICAL LITHOTRIPSY TO REMOVE THE STONE. AS A RESULT, THE PROCEDURE HAS BEEN CANCELLED. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR THREE (3) DAYS. THE PATIENT ELECTED NOT TO HAVE SURGERY, BUT TO HAVE LASER TO BREAK THE STONE. **ADDITIONAL INFORMATION RECEIVED ON 03SEP2024: THE PATIENT UNDERWENT AN ENDOSCOPIC PROCEDURE TO HAVE THE DETACHED BASKET RETRIEVED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19777556 ↗
• MalfunctionJul 18, 2024Difficult to Advance; Difficult to Open or Close; Difficult to Advance; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A SPYBASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2024. DURING THE PROCEDURE, THE BASKET WAS UNABLE TO OPEN WITHIN THE SPYGLASS CATHETER AND THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE BASKET. AS A RESULT, THE PROCEDURE HAS BEEN CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19777403 ↗
• InjuryDec 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE COMMON BILE DUCT DURIN A CHOLANGIOSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHILE TRYING TO GRASP THE STONE, THE WIRE BECAME DETACHED ABOUT 20 CENTIMETERS FROM THE TIP AND FELL INSIDE THE PATIENT. BOTH THE WIRE AND THE STONE WERE RETRIEVED TOGETHER USING AN OLYMPUS ROTATING FORCEPS. THE PROCEDURE WAS COMPLETED WITH THE OLYMPUS ROTATING FORCEPS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300523 ↗
• InjuryJul 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BASKET DETACHED INTO THE PATIENT'S COMMON BILE DUCT. THE DETACHED BASKET WAS RETRIEVED USING A RESCUE FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SPYBASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273744 ↗
• InjuryJun 26, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE COMMON BILE DUCT DURING A LAPAROSCOPIC CHOLECYSTECTOMY WITH COMMON BILE DUCT EXPLORATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING A PROCEDURE, A SPYGLASS RETRIEVAL BASKET WAS USED TO CAPTURE A LARGE STONE IN THE COMMON BILE DUCT. HOWEVER, WHEN THE BASKET WAS CLOSED, THE WIRE OF THE BASKET BROKE LEAVING THE STONE TRAPPED INSIDE. FURTHER INCISION ON THE PATIENT'S COMMON BILE DUCT WAS PERFORMED IN ORDER TO EXTRACT THE BROKEN BASKET AND STONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17197381 ↗
• InjurySep 9, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, A SPYGLASS RETRIEVAL BASKET WAS USED TO ATTEMPT TO REMOVE A STONE. THE BASKET CAPTURED THE STONE. HOWEVER, WHILE TAKING OUT THE SPYBASKET AND THE STONE, THE PULLWIRE BROKE. THE BASKET AND STONE REMAINED IN THE PATIENT. SEVERAL METHODS WAS PERFORMED TO REMOVE THE BASKET AND TOOK MORE THAN AN HOUR TO SUCCESSFULLY REMOVE THE BASKET FROM THE PATIENT. THE STONE WAS REMOVED FROM THE BASKET BY DILATING THE PAPILLA WITH A BALLOON AND THE BASKET WIRES WERE PRESSED HOWEVER THE STONE WAS UNABLE TO BE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS POSTPONED DUE TO THE LONG PROCEDURE TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391650 ↗
• MalfunctionJun 21, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE COMMON BILE DUCT DURING AN CHOLANGIOSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BASKET FAILED TO OPEN WHEN ATTEMPTING TO GRASP A STONE. THE PROCEDURE TOOK A LONGER TIME THAN EXPECTED; THEREFORE, THE PHYSICIAN ABORTED THE PROCEDURE AND DECIDED TO TRY AGAIN NEXT TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760496 ↗
• MalfunctionDec 28, 2021Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available; Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE BILE DUCT ON A STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SPYBASKET BASKET FAILED TO OPEN. THE PROCEDURE WAS NOT COMPLETED SINCE IT WAS TAKING LONGER THAN EXPECTED. THE PHYSICIAN DECIDED TO RETRIEVE THE STONE AT A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095335 ↗
• InjuryApr 22, 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 SPYBASKET WAS USED IN THE BILE DUCT DURING A PERCUTANEOUS BILE DUCT EXPLORATION WITH STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THE PHYSICIAN NOTICED A LEAKING OF CONTRAST MEDIUM INTO THE PERITONEUM INDICATING A SMALL GALLBLADDER PERFORATION DURING MULTIPLE STONE EXTRACTIONS WITH THE SPYGLASS RETRIEVAL BASKET. THE PHYSICIAN PLACED AN EXTERNAL/INTERNAL DRAIN AND IT WAS INDICATED THAT THE PATIENT WOULD BE BROUGHT BACK IN A WEEK OR TWO AFTER THE PROCEDURE DATE TO FURTHER REMOVE STONES. IT WAS REPORTED THAT THE PATIENT IS EXPECTED TO FULLY RECOVER. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Perforation

  MAUDE report 11705564 ↗
• MalfunctionFeb 10, 2021Difficult to Advance; Appropriate Device Problem Term/Code Not Available; Difficult to Advance; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND SPYGLASS RETRIEVAL BASKET USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND SPYGLASS RETRIEVAL BASKET WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYBASKET WAS UNABLE TO ADVANCE THROUGH THE SPYSCOPE DS II. REPORTEDLY, THE SPYBASKET GOT STUCK APPROXIMATELY 5-10 CM FROM THE DISTAL TIP OF THE SPYSCOPE DS II. REPORTEDLY, THE DUODENOSCOPE AND SPYSCOPE DS II WERE STRAIGHTENED TO TRY TO HELP MOVE THE ACCESSORY DEVICES THROUGH; HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. 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 11306761 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II ACCESS AND DELIVERY CATHETER AND A SPYGLASS RETRIEVAL BASKET THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS AND DELIVERY CATHETER AND A SPYGLASS RETRIEVAL BASKET WERE USED IN THE BILIARY SYSTEM DURING A CHOLANGIOSCOPY WITH BILIARY SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2020 AS PART OF THE E7131 NON COMPLEX BILIARY STONES RANDOMIZED CONTROL TRIAL (RCT) STUDY. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS ALREADY TAKING ANTIBIOTICS AND WAS GIVEN INDOMETHACIN PRIOR TO THE PROCEDURE. CANNULATION IN THE PANCREATIC DUCT WAS PERFORMED USING A SPHINCTEROTOME AND WIRE. CANNULATION WAS COMPLETED ONE TIME WITH THE EVENTUAL STANDARD BILIARY CANNULATION HAVING SUCCESS WITHIN 15 MINUTES OF INITIATING THE PROCEDURE. A SPYSCOPE DS II ACCESS AND DELIVERY CATHETER WAS USED AND THE IMAGE WAS REPORTEDLY GOOD. DURING CHOLANGIOSCOPY, TWO BILIARY STONES WERE SEEN ALONG WITH SLUDGE. BILIARY SPHINCTEROTOMY WAS THEN PERFORMED. A SPYGLASS RETRIEVAL BASKET WAS USED TO REMOVE THE STONES ALONG WITH THE SLUDGE OR DEBRIS. ON (B)(6) 2020, THE PATIENT PRESENTED WITH ACUTE PANCREATITIS. REPORTEDL

  Patient problems: Inflammation; No Code Available

  MAUDE report 11139766 ↗
• MalfunctionAug 19, 2020Entrapment of Device; Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROCEDURE PERFORMED IN THE CYSTIC DUCT ON (B)(6)2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYBASKET WAS PASSED TO RETRIEVE STONE FRAGMENTS; HOWEVER, THE BASKET BECAME IMPACTED IN THE CYSTIC DUCT. THEY TRIED TO OPEN AND CLOSE BASKET; HOWEVER, IT WOULD NOT MOVE. THEY CUT THE CATHETER OF BASKET BELOW THE HANDLE SO THAT THEY COULD REMOVE THE SPYBASKET; HOWEVER, THE BASKET CATHETER GOT STUCK IN THE WORKING CHANNEL OF THE SPYSCOPE DS II. ULTIMATELY THEY HAD TO CUT THE SPYSCPOE DS II CATHETER BELOW THE HANDLE TO REMOVE DUODENOSCOPE. THE SPYSCOPE DS II WAS SUCCESSFULLY REMOVED. THE BASKET WAS STILL IMPACTED IN THE PATIENT. REPORTEDLY, THE PATIENT WAS STENTED AND RESCHEDULED FOR A FOLLOW UP PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426845 ↗
• MalfunctionJul 21, 2020Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SPYGLASS PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE HANDLE BROKE AFTER SEVERAL ATTEMPTS TO OPEN THE SPYBASKET. REPORTEDLY, PRIOR TO PLACEMENT INSIDE THE PATIENT, THE DEVICE COULD OPEN AND CLOSE. REPORTEDLY, THE PHYSICIAN ALSO ATTEMPTED TO USE NON BSC BASKETS FOR STONE REMOVAL. HOWEVER, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PROCEDURE WAS RESCHEDULED. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302279 ↗
• InjuryJun 18, 2020Break; Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available; Break; Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE MAIN PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), CHOLANGIOSCOPY GUIDED LITOTHRIPSY AND PANCREATIC STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A DILATION WAS PERFORMED WITH A SOEHENDRA DILATOR NARROWING THE DISTAL OF THE STONE IN THE MAIN PANCREATIC DUCT. CHOLANGIOSCOPY AND LITHOTRIPSY WERE THEN PERFORMED USING A SPYSCOPE DS II AND AN AULOTILTH ONETOUCH EHL (ELECTROHYDRAULIC LITHOTRIPSY) PROBE, WHICH WAS NOT SUCCESSFUL. THE AUTOLITH PROBE WAS NOT POWERFUL ENOUGH TO CRASH THE STONE. REPORTEDLY, 260 PULSES OF EHL WERE DELIVERED WHEN ATTEMPTING TO BREAK UP THE STONE. AS A RESULT, A SPYBASKET WAS ATTEMPTED TO BE USED TO EXTRACT THE STONE. HOWEVER, THE STONE AND THE SPYBASKET GOT IMPACTED. AFTER MULTIPLE ATTEMPTS TO PULL THE STONE; THE HANDLE OF THE SPYBASKET GOT BROKEN. REPORTEDLY, THE PHYSICIAN APPLIED TOO MUCH FORCE WHILE TRYING TO PULL THE BASKET OUT OF THE DUCT. THE HANDLE DETACHED FROM THE WIRE AND IT REMAINED INSIDE OF THE PATIENT'S BILIARY SYSTEM. AN ARGON PLASMA COAGULATOR WAS USED TO CUT

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 10170178 ↗
• MalfunctionDec 12, 2019Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYBASKET WAS USED TO EXTRACT THE COMMON BILE DUCT STONE; HOWEVER, THE STONE WAS TOO LARGE TO BE PULLED OUT OF THE ORIFICE. THEY HAD TO RELEASE THE STONE BUT IT WOULD NOT COME OUT OF THE DEVICE, AND THE HANDLE OF THE SPYBASKET BROKE. THE PHYSICIAN SHEARED THE CATHETER IN ORDER TO GET THE BASKET TO OPEN TO RELEASE THE STONE. THE PROCEDURE WAS CONTINUE USING AN EHL (ELECTROHYDRAULIC LITHOTRIPSY) DEVICE TO BREAK THE STONE. THE PROCEDURE WAS COMPLETED WITH A SECOND SPYBASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457308 ↗
• MalfunctionNov 27, 2019Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED IN THE CYSTIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BASKET WITH THE STONE INSIDE, THE STONE IN THE SPYBASKET WOULD NOT RELEASE FROM THE CYSTIC DUCT. ADDITIONALLY, THE SPYBASKET HANDLE BROKE DUE TO MANIPULATION BY THE NURSE. THE HANDLE WAS MANUALLY CUT AND THE SPYSCOPE WAS REMOVED FROM THE BILE DUCT. A SOEHENDRA LITHOTRIPTER WAS USED TO BREAK THE STONE FROM THE SPYBASKET, ALLOWING THE SPYBASKET TO BE SAFELY REMOVED FROM THE CYSTIC DUCT AND THE BILE DUCT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN EHL PROBE. 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 9383544 ↗
• InjuryOct 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS RETRIEVAL BASKET WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH CHOLANGIOSCOPY AND STONE REMOVAL PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYGLASS RETRIEVAL BASKET WAS PASSED INTO THE PANCREATIC DUCT TO REMOVE STONE FRAGMENTS. STONES WERE REMOVED ON THE FIRST PASS. DURING THE SECOND PASS, STONES WERE COLLECTED IN THE BASKET. DURING REMOVAL OF THE BASKET, THE BASKET BECAME IMPACTED IN THE PAPILLARY ORIFICE. UPON REMOVAL OF THE SPYSCOPE AND DUODENAL SCOPE FROM THE PATIENT, THE INTERNAL WIRE OF THE CATHETER BROKE COMPLETELY AND DETACHED AND SEPARATED APPROXIMATELY 10 CM PROXIMAL TO THE BASKET, LEAVING THE BASKET IN THE PAPILLARY ORIFICE. THE CATHETER AND SCOPE WERE REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE BY USING EHL AND LASER LITHOTRIPSY TO BREAK UP THE IMPACTED STONES IN THE BASKET AND REMOVED THE BASKET USING A RAT-TOOTH FORCEPS. EVERYTHING WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A PANCREATIC DUCT STENT WAS PLACED AND THE PATIENT IS CURRENTLY IN RECOVERY POST PROCEDURE. THERE WERE NO PAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928107 ↗