Extractor™ Pro XL M00547110Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729790402), received between Oct 31, 2017 and Apr 8, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS BEING PREPARED FOR USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR BILE DUCT STONES TO BE PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE SYRINGE WAS REMOVED FOLLOWING BALLOON INFLATION. HOWEVER, THE BALLOON DID NOT DEFLATE AND REMAINED INFLATED. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823412 ↗
• MalfunctionNov 5, 2025Break; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT PRESENCE OF CALCULI IN THE BILIARY TRACT PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AT THE TIME OF EXTRACTING THE GALLSTONE THE BALLOON SPLIT IN TWO. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 FINDING OF DEVICE CATHETER DETACHED OR SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477442 ↗
• MalfunctionMar 13, 2024Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PATIENT WAS EXAMINED USING AN EXTRACTOR BALLOON. ALTHOUGH THE WIRE WAS ALREADY IN THE BILE DUCT, THE EXTRACTOR BALLOON COULD NOT BE INSERTED OVER THE WIRE. AN ATTEMPT WAS MADE TO PULL THE WIRE BACK A LITTLE, BUT UNFORTUNATELY, IT PROVED TO BE A BIT DIFFICULT. AFTER REMOVING THE EXTRACTOR BALLOON, IT WAS DISCOVERED THAT THE DISTAL TIP OF THE BALLOON WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899549 ↗
• MalfunctionMar 13, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE EXTRACTOR BALLOON WAS PUSHED INTO THE BILE DUCT, A KINK OCCURRED IN FRONT OF THE PAPILLA. THE EXAMINER THEN WANTED TO INSERT A JAGWIRE 0.035 TO PROVIDE SOME STIFFENING, BUT THIS WAS NOT POSSIBLE TO ADVANCE BECAUSE THE DISTAL TIP OF THE BALLOON WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899408 ↗
• MalfunctionJul 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE DISTAL COMMON BILE DUCT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283644 ↗
• MalfunctionFeb 16, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILIARY TRACT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH LITHOTRIPSY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AFTER PERFORMING THE EXCHANGE STEP TO LEAVE THE GUIDEWIRE IN THE BILIARY TRACT AND PASS THE BALLOON EXTRACTOR, THE DEVICE ADVANCED OVER THE GUIDEWIRE, ENTERED THE BILIARY TRACT AND WAS INSUFFLATED. CALCULI WAS EXTRACTED AND THE BALLOON WOULD NOT DEFLATE WHEN RE-ENTERING THE BILIARY TRACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THE CUSTOMER PROVIDED A VIDEO OF THE DEVICE BEING USED OUTSIDE THE PATIENT. THE VIDEO SHOWS THE BALLOON INFLATES CORRECTLY BUT, DOES NOT DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386615 ↗
• MalfunctionDec 22, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILIARY TRACT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH CALCULUS EXTRACTION PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED BUT THE BALLOON WOULD NOT DEFLATE WHEN RE-ENTERING THE BILIARY TRACT. THE BALLOON WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN CUT THE BALLOON TO REMOVE IT FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039819 ↗
• MalfunctionJun 30, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS INTENDED TO BE USED IN THE COMMON BILE DUCT (CBD) FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTED THAT THE SHAPE OF THE BALLOON WAS IRREGULAR, WHICH WAS CONFIRMED VIA A PHOTO SUBMITTED BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876756 ↗
• MalfunctionJun 2, 2022Use of Device Problem; Device Contamination with Chemical or Other Material; Use of Device Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, A SALINE SOLUTION WAS INJECTED INTO THE GUIDEWIRE PORT AND RESISTANCE WAS FELT. IT WAS ALSO NOTED THAT A 2-3 ML GEL-LIKE MATERIAL WAS PUSHED OUT FROM THE LUMEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14581104 ↗
• MalfunctionJun 2, 2022Use of Device Problem; Device Contamination with Chemical or Other Material; Use of Device Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, A SALINE SOLUTION WAS INJECTED INTO THE GUIDEWIRE PORT AND RESISTANCE WAS FELT. IT WAS ALSO NOTED THAT A 2-3 ML GEL-LIKE MATERIAL WAS PUSHED OUT FROM THE LUMEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580964 ↗
• MalfunctionJun 2, 2022Use of Device Problem; Device Contamination with Chemical or Other Material; Use of Device Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, A SALINE SOLUTION WAS INJECTED INTO THE GUIDEWIRE PORT AND RESISTANCE WAS FELT. IT WAS ALSO NOTED THAT A 2-3 ML GEL-LIKE MATERIAL WAS PUSHED OUT FROM THE LUMEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580900 ↗
• MalfunctionDec 23, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13077956 ↗
• MalfunctionFeb 22, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON DEVICE WAS USED IN THE COMMON BILE DUCT (CBD) STONE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER SHEARED IN HALF AS IT WAS BEING ADVANCED INTO THE WORKING CHANNEL OF THE DUODENOSCOPE. IT WAS REPORTED THAT NOTHING DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362179 ↗
• MalfunctionJan 27, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE PRONE POSITION DURING A CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE DISTAL TIP DETACHED/SEPARATED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11236342 ↗
• MalfunctionJul 9, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT BE DEFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251007 ↗
• MalfunctionApr 6, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER BROKE INTO TWO SEPARATE PARTS WITHIN THE SCOPE WORKING CHANNEL. REPORTEDLY, A PIECE DETACHED INTO THE PATIENT AND WAS RETRIEVED BY BEING CAUGHT WITH THE ELEVATOR AND THEN PULLED OUT WITH THE DUODENOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9930687 ↗
• MalfunctionFeb 11, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER BROKE IN THE SCOPE WORKING CHANNEL INTO TWO SEPARATE PARTS. REPORTEDLY, A PIECE OF THE DEVICE DETACHED INSIDE THE PATIENT AND WAS RETRIEVED USING THE ELEVATOR OF THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9696035 ↗
• MalfunctionOct 10, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON 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, THE CATHETER BROKE IN TWO SEPARATE PIECES IN THE WORKING CHANNEL. THE DISTAL PIECE FELL INTO THE PATIENT AND WAS RETRIEVED WITH THE ELEVATOR OF THE DUODENOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176401 ↗
• MalfunctionJul 29, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON 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, THE CATHETER BROKE IN HALF. REPORTEDLY, NO PART OF THE DEVICE DETACHED IN THE PATIENT, AND THE CATHETER WAS SAFELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8838120 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE CHOLEDOCH DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE DEVICE CAUSED A PERFORATION IN THE BILIARY TRACT. THE TIP WAS NOTED TO BE VERY RIGID, THOUGH THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICE. NO TREATMENT OR INTERVENTION WAS PERFORMED FOR THE PERFORATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Perforation

  MAUDE report 8570008 ↗
• MalfunctionFeb 20, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON 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, THE CATHETER WAS BROKEN INTO TWO SEPARATE PIECES. REPORTEDLY, THE DOCTOR CAUGHT THE DETACHED PIECES THROUGH AN ELEVATOR AND PULLED OUT FROM THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO XL RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353833 ↗
• MalfunctionOct 31, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER SHAFT WAS TORN IN THE MIDDLE WHEN THE STONES WERE REMOVED FROM THE BILE DUCT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS SHOWED THAT THE CATHETER SHAFT WAS BROKEN INTO TWO PIECES; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6990409 ↗