Extractor™ Pro RX M00547000Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 08714729790266), received between Dec 22, 2017 and Aug 28, 2026 — classified as 1 death, 16 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (20 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 28, 2025Open, Classified

   The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

   Z-2618-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Difficult to Advance; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488968 ↗
• MalfunctionJun 18, 2026Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOONS WAS ATTEMPTED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR STONE REMOVAL IN COMMON BILE DUCT PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE DUCT WAS SWEPT AND DEBRIS WAS REMOVED. UPON WITHDRAWAL OF THE BALLOON CATHETER, THE DISTAL TIP OF THE CATHETER DETACHED AND WAS LEFT IN THE DUODENUM. THE BALLOON ITSELF REMAINED INTACT AND DID NOT SEPARATE INTO THE PATIENT. THE PHYSICIAN WAS NOT USING A GUIDEWIRE DURING THE PROCEDURE, AND IT APPEARS THE CATHETER TIP BENT AND SUBSEQUENTLY BROKE. THE PROCEDURE WAS COMPLETED WITH SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25553583 ↗
• DeathApr 7, 2026Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO AN EXTRACTOR PRO RETRIEVAL BALLOON AND WALLFLEX BILIARY STENTS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT METASTATIC PANCREATIC CANCER AND COMMON BILE DUCT OBSTRUCTION PERFORMED ON (B)(6) 2026. POST PROCEDURE, 6 MONTHS AFTER STENT IMPLANTATION, A PARTIALLY COVERED METAL BILIARY STENT WAS REPORTED TO HAVE BEEN OCCLUDED. DURING AN ERCP PERFORMED FOR AN OCCLUDED PANCREATIC CANCER RELATED BILIARY METAL STENT, AN EXTRACTOR BALLOON WAS USED TO SWEEP OBSTRUCTING SLUDGE FROM THE DUCT, AND IT WAS SUSPECTED THAT SIMPLY SWEEPING THE DUCT LED TO A DISLODGING OF A CLOT, WHICH RESULTED IN BLEEDING. SPYGLASS VISUALIZATION REVEALED A PULSATILE BLEEDING SITE LOCATED A CM OR TWO ABOVE THE PROXIMAL END OF THE STENT CONCERNING FOR VASCULAR EROSION. MULTIPLE HEMOSTATIC MEASURES WERE ATTEMPTED, INCLUDING USE OF A HURRICANE BALLOON, EPINEPHRINE INJECTION, AND PLACEMENT OF A FULLY COVERED METAL STENT. DESPITE THESE EFFORTS, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE, REQUIRED

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; Reduced Blood Flow

  MAUDE report 24809037 ↗
• InjuryDec 8, 2025Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component; Difficult to Remove; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONES AND INDETERMINATE STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER SEVERAL PASSES AND RETRIEVAL ATTEMPTS, THE BALLOON CATHETER COULD NOT BE REMOVED FROM THE DUCT, LIKELY LODGED BETWEEN THE STONE, STRICTURE, AND DUCT WALL. DESPITE APPLYING SIGNIFICANT TRACTION, THE CATHETER COULD NOT BE REMOVED. THE CATHETER WAS CUT OUTSIDE THE SCOPE TO WITHDRAW THE SCOPE, THEN REINTRODUCED THE SCOPE AND TRIMMED THE CATHETER WITHIN THE DUODENUM, LEAVING ONLY A MINIMAL PORTION PROTRUDING FROM THE COMMON BILE DUCT. AFTER THE FINAL CUT, THE DISTAL TIP DISLODGED AND FLOATED ABOVE THE STRICTURE. ATTEMPTS TO RETRIEVE THE TIP USING STRICTURE DILATION VIA SPYGLASS DS, AND SPYBITE MAX WERE UNSUCCESSFUL BECAUSE THE COMMON BILE DUCT WAS TOO DILATED AND THE TIP WAS FLOATING AROUND TOO MUCH. CONSEQUENTLY, A 10X60 WALLFLEX FULLY COVERED STENT WAS PLACED TO OPEN UP THE STRICTURE AND POSSIBLY HAVE THE TIP OF THE CATHETER FALL THROUGH THE STENT AND OUT OF THE DUCT. THERE WER

  Patient problems: Foreign Body In Patient

  MAUDE report 23752441 ↗
• InjuryOct 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS DILATED WITH CONTRAST AND BALLOON BEGAN LEAKING SHORTLY AFTER BEING DILATED. IT WAS REPORTED THAT A SERIOUS INJURY THAT REQUIRED INTERVENTION OCCURRED. ADDITIONAL CLARIFICATION REGARDING THE NATURE OF THE SERIOUS INJURY OR THE TYPE OF REQUIRED INTERVENTION WAS NOT PROVIDED. NO FURTHER INFORMATION IS ABLE TO BE OBTAINED AS THE HEALTHCARE FACILITY AND INITIAL REPORTER WAS NOT REPORTED ON THE MEDWATCH FORM AND IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23364439 ↗
• MalfunctionAug 4, 2025Break; 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 TO TREAT GALLSTONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER CRACKED/BROKE WHEN USING THE EXTRACTOR PRO RX. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708816 ↗
• MalfunctionJul 16, 2025Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE BALLOON WOULD NEVER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22525374 ↗
• InjuryJun 17, 2025Burst Container or Vessel; Burst Container or Vessel

  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) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT A SERIOUS INJURY THAT REQUIRED INTERVENTION OCCURRED. ADDITIONAL CLARIFICATION REGARDING THE NATURE OF THE SERIOUS INJURY OR THE TYPE OF REQUIRED INTERVENTION WAS NOT PROVIDED. NO FURTHER INFORMATION IS ABLE TO BE OBTAINED AS THE REPORTER ASKED TO REMAIN CONFIDENTIAL.

  Patient problems: Insufficient Information

  MAUDE report 22238253 ↗
• MalfunctionOct 9, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO 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 20407369 ↗
• MalfunctionAug 5, 2024Inflation Problem; Difficult to Remove; Failure to Deflate; Inflation Problem; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE ON INITIAL ATTEMPT. UPON EVENTUAL INFLATION, THE BALLOON WOULD NOT DEFLATE AFTER SEVERAL ATTEMPTS AND REMOVAL OF INFLATION SYRINGE. THE BALLOON WAS PARTIALLY DEFLATED BEFORE REMOVING OUT OF THE PATIENT OR SCOPE. THE PROCEDURE WAS COMPLETED WITH A LARGER EXTRACTOR PRO RETRIEVAL BALLOON (12 MM -15 MM). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19909674 ↗
• InjuryMay 16, 2024Failure to Advance; Failure to Advance

  NOTE: THIS REPORT PERTAINS TO TWO JAGTOME REVOLUTION PRO RX 39 AND AN EXTRACTOR PRO RETRIEVAL BALLOON USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN UNINTENTIONALLY CANNULATED THE PANCREATIC DUCT THREE TIMES, BUT WAS ABLE TO SUCCESSFULLY CANNULATE THE COMMON BILE DUCT. CONTRAST WAS INJECTED AND A NORMAL COMMON BILE DUCT WAS VISUALIZED. THE SPHINCTEROTOME WAS THEN PULLED BACK TO PERFORM SPHINCTEROTOMY. THE PHYSICIAN HAD THE INSULATED PORTION OF THE CUT WIRE TRAVERSING THE AMPULLA ORIFICE BUT CONTINUED TO APPLY UPWARD FORCE AND CAUTERY. THERE WAS BLEEDING BEYOND THE AMPULLA THROUGHOUT THE REST OF THE CASE. THE PHYSICIAN THEN REMOVED THE SPHINCTEROTOME AND AN EXTRACTOR PRO RETRIEVAL BALLOON WAS ADVANCED OVER THE GUIDEWIRE WITHOUT DIFFICULTY UNTIL HE ENTERED THE PROXIMAL CBD AT WHICH POINT HE WAS NOT ABLE TO ADVANCE THE BALLOON ANY FURTHER. EVENTUALLY, THE BALLOON WAS REMOVED AND WHILE WAITING FOR THE NEXT BALLOON THE PHYSICIAN LOST ACCESS TO TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19336228 ↗
• MalfunctionNov 20, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON OCTOBER 30, 2023. DURING THE PROCEDURE, THE CATHETER BROKE WHEN THE BALLOON WAS ATTEMPTED TO BE REMOVED FROM THE DUCT. A PHOTO SUBMITTED BY THE CUSTOMER SHOWED THAT THE CATHETER BROKE INTO TWO SEPARATE PIECES. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON CATHETER DETACHED INSIDE THE PATIENT. 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 18179057 ↗
• MalfunctionNov 8, 2023Entrapment 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 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE TIP OF THE BALLOON DETACHED FROM THE CATHETER ON WITHDRAWAL AND GOT STUCK IN THE AUTOCAP RX. THE DOCTOR TOOK OFF THE AUTOCAP AND PUSHED THE BROKEN TIP OUT WITH ANOTHER EXTRACTOR PRO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18095196 ↗
• MalfunctionOct 11, 2023Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, THE TIP OF THE BALLOON NO LONGER GUIDED THE WIRE. IT WAS ALSO SPLIT AT THE TOP. 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 17912480 ↗
• InjuryJul 19, 2023Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  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) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS DIFFICULT TO FEED THE BALLOON CATHETER THROUGH THE AUTOCAP LOCKING DEVICE, CAUSING THE CATHETER TO KINK DURING THE SURGERY. ADDITIONALLY, IT WAS QUITE CHALLENGING TO GET THE GUIDEWIRE TO GO INTO AND OUT OF THE DUCT AND THE DISTAL PART OF THE BALLOON. THE USER SWITCHED TO ANOTHER OF THE SAME BALLOON AND DISCOVERED THAT THE TIP OF THE BALLOON WAS PROTRUDING FROM THE AMPULLA AS IT WAS PUSHED OUT OF THE SCOPE. THE DISTAL TIP AT THE RADIOPAQUE (RO) MARKER DETACHED FROM THE DEVICE INSIDE THE PATIENT. AFTER REMOVING THE REMAINING BALLOON DEVICE FROM THE PATIENT, THE PHYSICIAN WAS ABLE TO PULL OUT THE BROKEN TIP WITH RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THE CUSTOMER PROVIDED A PHOTO OF THE DEVICE. THE PHOTO SHOWS THE TIP OF THE BALLOON DETACHED INSIDE THE PATIENT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17357052 ↗
• MalfunctionJul 5, 2023Detachment 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 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE TIP OF THE BALLOON BROKE OFF AND FELL INTO THE PATIENTS INTRAHEPATIC DUCT. THE PROCEDURE HAD ALREADY BEEN COMPLETED WITH THE ORIGINAL DEVICE AND THE DETACHED COMPONENT WAS NOT RETRIEVED FROM INSIDE THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262803 ↗
• MalfunctionApr 6, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 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 PROCEDURE, THE BALLOON WAS DIFFICULT TO PASS AND ADVANCE INTO THE COMMON BILE DUCT. THE CATHETER WAS NOTED TO BE BROKEN. THE CUSTOMER STATED THAT NO PIECES OF THE DEVICE 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693874 ↗
• MalfunctionMar 22, 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 THE COMMON BILE DUCT (CBD) FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION OUTSIDE THE PATIENT, THE BALLOON WOULD NOT COME OUT OF THE BLUE CATHETER. THE USER TUGGED HARDER AND BROKE THE BALLOON CATHETER INTO TWO SEPARATE PIECES. ANOTHER DEVICE WAS OPENED, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16592594 ↗
• MalfunctionFeb 16, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS UNPACKED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTICED THAT THE DEVICE WAS BROKEN IN THE PACKAGE, WHICH WAS CONFIRMED VIA A PHOTO SUBMITTED BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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 16390583 ↗
• MalfunctionAug 11, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS OPENED FOR A PROCEDURE TO BE USED IN THE BILIARY PERFORMED ON (B)(6), 2022. DURING PREPARATION, THE BALLOON WAS INFLATED BUT THEY NOTICED THAT THE BALLOON WOULD NOT DEFLATE ONCE COMPLETELY INFLATED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15208870 ↗
• MalfunctionJul 25, 2022Difficult to Advance; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO A DREAMTOME RX 44 AND AN EXTRACTOR PRO RX THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX 44 AND AN EXTRACTOR PRO RX WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THERE WAS A LOT OF RESISTANCE WHEN ADVANCING THE PRELOADED GUIDEWIRE THROUGH THE TOME. THE GUIDEWIRE KEPT ON GETTING STUCK IN THE TOME. WHEN THE GUIDEWIRE WAS USED WITH THE EXTRACTOR PRO RX, IT ALSO SLIPPED OUT OF THE C-CHANNEL. 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 15099706 ↗
• MalfunctionJul 25, 2022Deflation 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) 2022. DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED; HOWEVER, IT COULD NOT BE DEFLATED. THE DEVICE WAS REMOVED WITH THE SCOPE FROM THE PATIENT, AND THE DEVICE WAS CUT IN ORDER TO BE REMOVED FROM THE SCOPE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15099671 ↗
• MalfunctionJun 15, 2022Detachment 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 BILIARY SYSTEM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6)2022. ACCORDING TO THE COMPLAINANT, WHILE PULLING THE DEVICE OUT OF THE SCOPE, IT WAS NOTED THAT THE END OF THE CATHETER COMPLETELY BROKE OFF IN TWO SEPARATE PIECES. NOTHING DETACHED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14709551 ↗
• MalfunctionMay 26, 2022Detachment 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) 2022. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP CAME OFF OF THE BALLOON AND WAS ON WIRE EVEN WHEN THE BALLOON HAD BEEN REMOVED. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518660 ↗
• MalfunctionApr 19, 2022Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  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) 2022. DURING THE PROCEDURE, THE PHYSICIAN ASKED TO PUT THE BALLOON TO 9MM; HOWEVER, THE BALLOON WAS NOT INFLATED WHEN THE BALLOON WAS PULLED OUT OF DUCT. PRIOR TO REINSERTING BACK INTO DUCT THE BALLOON WAS INFLATED AND DEFLATED A COUPLE OF TIMES, THE BALLOON DID INFLATE BUT DID NOT STAY UP AT 9MM, ONLY 12MM. ADDITIONALLY, THE BALLOON SHAPE AND SIZE WAS NOTED TO BE ODD AND NOT ROUNDED, THE ONE SIDE WAS UNDER-INFLATED AND DID NOT LOOK LIKE IT WAS INFLATED ALL THE WAY TO 12MM. THE BALLOON WAS THEN REMOVED FROM THE DUCT, THE STOPCOCK WAS OPENED BUT THE BALLOON DID NOT AUTOMATICALLY DEFLATE AND THE SYRINGE PLUNGER HAD TO BE PHYSICALLY PULLED BACK. 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 14147932 ↗