Extractor™ Pro RX M00547010Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729790297), received between Jun 1, 2017 and Sep 29, 2026 — classified as 1 death, 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937591 ↗
• MalfunctionSep 21, 2026Burst Container or Vessel; Inflation Problem; Use of Device Problem; Failure to Deflate

  It was reported to Boston Scientific Corporation that an Extractor Pro RX Retrieval Balloon was attempted to be used during a Cholangiogram procedure to treat gall stones performed on (b)(6) 2026.During the procedure, it was reported that the physician and nurses were unable to deflate device. It was reported that they overfilled in order to pop balloon to extract it. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.Note: It was reported that, they overfilled in order to pop balloon to extract it. However, per the Instruction for Use (IFU): Inflate the balloon to the appropriate size indicated for the device. Do not exceed the maximum balloon diameter as indicated on the enclosed pre-staked syringe when inflated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50835105 ↗
• MalfunctionMay 14, 2026Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE EXTRACTOR BALLOON SNAPPED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CATHETER WAS DETACHED OR SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178435 ↗
• MalfunctionApr 1, 2026Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE PROCEDURE FOR CBD STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS NOTICED TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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 24761376 ↗
• MalfunctionMar 11, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX WAS PREPARED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PREPARATION, THE CUSTOMER REPORTED SEEING A SMALL DARK HAIR INSIDE THE TRANSPARENT PACKAGING, APPEARING AS A FOREIGN BODY WITHIN THE STERILE DEVICE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576000 ↗
• DeathMay 7, 2025Adverse 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 RX RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN (B)(6) 2025. THE EXACT PROCEDURE DATE WAS NOT REPORTED. DURING THE PROCEDURE, A PERFORATION OCCURRED NEAR THE DUODENUM. IT WAS REPORTED THAT THE PHYSICIAN SUSPECTS THAT THE EXTRACTOR PRO RX RETRIEVAL BALLOON MAY BE A CONTRIBUTING FACTOR IN CAUSING THE PERFORATION. THE PROCEDURE WAS COMPLETED USING THE SAME ORIGINAL DEVICE. THE PATIENT PASSED AWAY IN (B)(6) 2025 DUE TO PERITONITIS. THE EXACT PATIENT DEATH DATE WAS NOT REPORTED.

  Patient problems: Perforation; Peritonitis

  MAUDE report 21978283 ↗
• MalfunctionDec 25, 2024Crack; Failure to Deflate; Crack; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A CATHETER CRACK WAS NOTED ON THE CHANNEL LEVEL AT THE TIME OF INFLATING THE BALLOON. THEREAFTER, THE DEVICE COULD NOT BE DEFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. 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 21016457 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE NURSE DISCOVERED THE DEVICE WAS BROKEN INTO TWO PIECES WHEN REMOVING IT FROM THE PACKAGE. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE DEVICE PACKAGING. 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 20894258 ↗
• MalfunctionJun 7, 2023Break; 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 AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE STONE EXTRACTION PROCEDURE, THE MIDDLE OF THE BALLOON CATHETER WAS NOTED TO HAVE SNAPPED INTO HALF. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 17080300 ↗
• MalfunctionSep 20, 2022Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC EXTRACTION OF BILIARY STONES PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON DID NOT INFLATE. THE PROCEDURE COULD NOT BE COMPLETED AS THE CUSTOMER DID NOT HAVE A SUBSTITUTE 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 15455869 ↗
• InjuryJul 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS FOUND THAT THE TIP OF THE BALLOON HAD DETACHED INSIDE THE PATIENT. REPORTEDLY, THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. 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 12198350 ↗
• MalfunctionJul 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE BALLOON BROKE OFF. 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 12131861 ↗
• MalfunctionMay 24, 2021Failure to Advance; Physical Resistance/Sticking

  PATIENT WITH HISTORY OF INCREASED JAUNDICE AND LIVER MASS UNDERWENT AN OUTPATIENT ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) WITH ANESTHESIA. DURING THE PROCEDURE, THE EXTRACTOR PRO RX TRIPLE-LUMEN RETRIEVAL BALLOON 12/15MM WOULD NOT SLIDE THROUGH THE SCOPE. THE DEVICE GOT STUCK, AND WOULD NOT GO IN ALL THE WAY. EXTRACTOR PRO RX TRIPLE-LUMEN RETRIEVAL BALLOON REMOVED INTACT, AND ANOTHER DEVICE USED WITHOUT PROBLEMS. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869514 ↗
• MalfunctionFeb 15, 2021Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON DEVICE WAS USED IN THE COLON DURING A COLONIC STENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE DISTAL TIP OF THE CATHETER UNKNOWINGLY DETACHED INSIDE THE SCOPE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AT THIS TIME. IT WAS ONLY DISCOVERED DURING ROUTINE CLEANING OF THE SCOPE AFTER THE PROCEDURE WHEN WATER COULD NOT BE FLUSHED THROUGH THE SCOPE; REPORTEDLY, A GUIDEWIRE WAS THEN PLACED INSIDE THE WORKING CHANNEL WHICH REMOVED THE DETACHED TIP FROM THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329817 ↗
• MalfunctionJan 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHILE SWEEPING THE BILE DUCT DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON TIP WAS DAMAGED. ADDITIONAL CLARIFICATION TO DETERMINE THE DAMAGE TO THE BALLOON TIP HAS NOT BEEN PROVIDED. REPORTEDLY, THE DEVICE AND DUODENOSCOPE WERE THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11116216 ↗
• MalfunctionDec 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX 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, IT WAS NOTED THAT THE TIP OF THE DEVICE BROKE OFF IN THE STOMACH OF A PATIENT. REPORTEDLY, THE TIP COULD NOT BE REMOVED FROM THE PATIENT. 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 Consequences Or Impact To Patient

  MAUDE report 10924696 ↗
• MalfunctionNov 25, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX 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 PREPARATION, IT WAS NOTED THAT THE BALLOON WOULD NOT FULLY DEFLATE. 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 Consequences Or Impact To Patient

  MAUDE report 10899921 ↗
• MalfunctionNov 16, 2020Break; Burst Container or Vessel; Stretched; Material Deformation; Break; Burst Container or Vessel; Stretched; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX 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 BALLOON BURST WHILE ATTEMPTING TO BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE CATHETER DETACHED IN TWO SECTIONS; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10845138 ↗
• InjuryOct 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON DEVICE 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, THE DISTAL TIP OF THE CATHETER UNKNOWINGLY DETACHED INTO THE BILE DUCT OF THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AT THAT TIME. IT WAS NOTED THAT THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IN (B)(6) 2020, THE PATIENT WAS TRANSFERRED TO A SECOND FACILITY FOR AN INTERVENTIONAL RADIOLOGY (IR). DURING A CT SCAN FOR SUSPECTED LIVER ABSCESS, THE DETACHED TIP OF THE CATHETER WAS THEN DISCOVERED INSIDE THE PATIENT. REPORTEDLY, THE PATIENT WAS REFERRED TO A THIRD FACILITY FOR ANOTHER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO RETRIEVE THE DETACHED TIP AND FOR SPYGLASS AND T-TUBE PLACEMENT.

  Patient problems: No Code Available

  MAUDE report 10720793 ↗
• MalfunctionOct 20, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX 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 BALLOON INFLATED SPONTANEOUSLY AND COULD NOT BE DEFLATED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10704888 ↗
• MalfunctionJun 23, 2020Crack; Stretched; Detachment of Device or Device Component; Crack; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON GOT SEPARATED FROM CATHETER. THE BALLOON WAS RETRIEVED FROM THE ENDOSCOPE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE DISTAL TIP OF THE CATHETER DETACHED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183452 ↗
• MalfunctionJan 21, 2020Break; Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Break; Difficult to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE EXPERIENCED DIFFICULTY ADVANCING DOWN THE ENDOSCOPE. IT WAS NOTED THAT THE DEVICE NEVER LEFT THE SCOPE. UPON REMOVAL OF THE DEVICE, THE CATHETER SEEMED TO HAVE BEEN CUT HORIZONTALLY ABOVE THE RADIOPAQUE MARKER, AND THE BALLOON WAS NOTED TO BE TORN. A PHOTO SENT BY THE CUSTOMER CONFIRMED THE CATHETER BREAK, AS WELL AS A KINK ON THE CATHETER. 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 Consequences Or Impact To Patient

  MAUDE report 9612138 ↗
• MalfunctionDec 27, 2019Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE EXTRACTOR PRO RETRIEVAL BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE EXTRACTOR PRO RX RETRIEVAL BALLOON DEVICES WERE 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 NOTED THAT THE CATHETER BROKE WHEN ATTEMPTED TO EXTRACT THE STONE. THE SAME ISSUE OCCURRED ON THE SECOND AND THIRD EXTRACTOR PRO RETRIEVAL BALLOONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE HAVE BEEN 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 Consequences Or Impact To Patient

  MAUDE report 9527205 ↗
• MalfunctionDec 27, 2019Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE EXTRACTOR PRO RETRIEVAL BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE EXTRACTOR PRO RX RETRIEVAL BALLOON DEVICES WERE 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 NOTED THAT THE CATHETER BROKE WHEN ATTEMPTED TO EXTRACT THE STONE. THE SAME ISSUE OCCURRED ON THE SECOND AND THIRD EXTRACTOR PRO RETRIEVAL BALLOONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE HAVE BEEN 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 Consequences Or Impact To Patient

  MAUDE report 9527204 ↗
• MalfunctionDec 27, 2019Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE EXTRACTOR PRO RETRIEVAL BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE EXTRACTOR PRO RX RETRIEVAL BALLOON DEVICES WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON DECEMBER (B)(6) ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER BROKE WHEN ATTEMPTED TO EXTRACT THE STONE. THE SAME ISSUE OCCURRED ON THE SECOND AND THIRD EXTRACTOR PRO RETRIEVAL BALLOONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE HAVE BEEN 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 Consequences Or Impact To Patient

  MAUDE report 9527203 ↗