CRE™ PRO M00558600Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729797487), received between Sep 14, 2018 and Apr 28, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (22 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT PAPILLARY ORIFICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR PANCREATIC DUCT STONES PERFORMED ON (B)(6) 2026. DURING UNPACKING, THE PHYSICIAN OBSERVED A SLIGHT CRACK IN THE BALLOON PRIOR TO USE. DESPITE THIS OBSERVATION, THE BALLOON WAS INTRODUCED INTO THE PATIENTS BODY. DURING PROCEDURE, THE BALLOON FRACTURED INTO TWO SEPARATE SECTIONS DURING INFLATION AND PRESSURIZATION. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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. THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD NOT BE USED IF MATERIAL DAMAGE IS FOUND PRIOR TO ITS USE. HOWEVER, THE CUSTOMER REPORTED THAT THE BALLOON WAS FOUND DAMAGED DURING UNPACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023830 ↗
• MalfunctionApr 14, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON BURST AND COULD NOT BE USED. 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 24874542 ↗
• MalfunctionApr 8, 2026Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT PAPILLARY OPENING DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE PAPILLARY OPENING OF BILE DUCT WAS PRE-DILATED, THE BALLOON WAS BURST AT 8MM AND THE CONTRAST MEDIUM LEAKED. IT WAS REPORTED THAT NO PIECES 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. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823745 ↗
• MalfunctionMar 30, 2026Leak/Splash; Mechanical Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT PAPILLARY ORIFICE TO TREAT BILE DUCT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PAPILLARY ORIFICE OF BILE DUCT WAS PRE-DILATED, THE BALLOON WAS DAMAGED AND THE CONTRAST MEDIUM LEAKED. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE INNER SHEATH IN THE BALLOON SECTION WAS BROKEN. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731723 ↗
• MalfunctionMar 11, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR A TUMOR PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS FOUND TO BE RUPTURED WHEN THE BALLOON WAS USED. 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 24569205 ↗
• MalfunctionMar 10, 2026Burst Container or Vessel; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR A TUMOR PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS FOUND TO BE RUPTURED WHEN THE BALLOON WAS USED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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 24563758 ↗
• MalfunctionFeb 9, 2026Inflation Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED. AFTER REMOVED FROM THE BODY, IT WAS FOUND THAT THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A BALLOON DAMAGE (BALLOON TORE). PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293929 ↗
• MalfunctionJan 13, 2026Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A COMMON BILE DUCT STONE AND YELLOW SCLERA PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS FOUND TO BE BURST AND LEAKING LIQUID DURING DILATION OF THE PAPILLA. IT WAS REPORTED THAT THE BALLOON BURST AT 6MM, BUT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. 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 24053146 ↗
• MalfunctionDec 16, 2025Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT PAPILLARY ORIFICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, PRE-EXPANSION OF THE BILE DUCT PAPILLA WAS PERFORMED, BUT THE BALLOON WAS DAMAGED AND WAS LEAKING THE CONTRAST AGENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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. CORRECTION WAS NOTED ON JANUARY 02, 2026. IT WAS REPORTED THAT THE DAMAGED NOTED ON THE BALLOON WAS THAT THERE WAS A SMALL HOLE ON THE BALLOON, THROUGH WHICH THE LIQUID WAS LEAKING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813335 ↗
• MalfunctionDec 2, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT PAPILLARY ORIFICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN PRE-DILATING THE BILE DUCT PAPILLA, THE DILATION BALLOON RUPTURED AT 3 ATM (6 MM) AND THE CONTRAST AGENT LEAKED OUT. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694356 ↗
• MalfunctionNov 9, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE BILE DUCT PAPILLARY ORIFICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN PRE-DILATING THE BILE DUCT PAPILLA, THE DILATATION BALLOON RUPTURED, AND THE CONTRAST AGENT LEAKED. 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 AND 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 23507049 ↗
• MalfunctionNov 5, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE BILE DUCT PAPILLARY ORIFICE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN PRE-DILATING THE BILE DUCT PAPILLA, THE DILATATION BALLOON RUPTURED AT 3ATM (6 MM DIAMETER), AND THE CONTRAST AGENT LEAKED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478317 ↗
• MalfunctionSep 4, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLARY DILATATION BALLOON (EPBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22973933 ↗
• MalfunctionAug 21, 2025Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE BILE DUCT PAPILLARY OPENING DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A PRE DILATION ON THE PAPILLARY OPENING OF THE BILE DUCT WAS PERFORMED AND IT WAS NOTED THAT THE BALLOON WAS DAMAGED, AND THE CONTRAST MEDIUM LEAKED DURING DILATATION. 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. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. BASED ON THE EVENT THAT THE BALLOON WAS DAMAGED, THE REPORTED EVENT MAY SUGGEST THAT THE BALLOON MIGHT BE BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861983 ↗
• MalfunctionMar 31, 2025Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A SECOND CRE PRO WIREGUIDED DILATATION BALLOON. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734568 ↗
• MalfunctionAug 21, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011993 ↗
• MalfunctionJun 3, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THE BALLOON BURST. 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 19454203 ↗
• MalfunctionMay 22, 2024Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PLUS PAPILLA OPENING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST AT 6 ATM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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 19374532 ↗
• MalfunctionOct 25, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC PAPILLARY LARGE BALLOON DILATION (EPLBD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004520 ↗
• MalfunctionOct 24, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC PAPILLARY LARGE BALLOON DILATION (EPLBD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000367 ↗
• MalfunctionOct 16, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT THE BALLOON BURST. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17943832 ↗
• MalfunctionSep 27, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. THE CUSTOMER REPORTED THE BALLOON BURST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17827720 ↗
• MalfunctionJun 15, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE 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 17135503 ↗
• MalfunctionAug 17, 2021Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, OUTSIDE THE PATIENT, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD NOT BE PRE-INFLATED PRIOR TO USE IN THE PROCEDURE. HOWEVER, THE CUSTOMER REPORTED THAT THE BALLOON WAS PRE-INFLATED OUTSIDE OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334683 ↗
• MalfunctionJun 25, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPAHGUS DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CONTRAST MEDIA WAS LEAKING FROM THE BALLOON AND IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER A CRE PRO WIREGUIDED DILATATION BALLOON . THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071165 ↗