CRE™ PRO M00558630Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729797517), received between Aug 23, 2018 and Sep 22, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (14 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.

• MalfunctionSep 22, 2026Inflation Problem; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862791 ↗
• MalfunctionSep 22, 2026Inflation Problem; Leak/Splash

  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) 2026.During the procedure, it was reported that the customer was unable to inflate the ballon as there was fluid coming out and was leaking. The procedure was completed with another of the same device. The anatomy location of the procedure is unknown and is being reported as the balloon leak may have occurred in the esophagus.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 50849680 ↗
• MalfunctionJun 4, 2026Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PRO WIREGUIDED DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE PRO WIREGUIDED DILATATION BALLOON WERE ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, THE BALLOON WAS OBSERVED TO BE LEAKING AND WAS FOUND TO HAVE SMALL HOLES. THE SAME PROBLEM WAS ALSO ENCOUNTERED WITH THE SECOND CRE PRO WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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 EXAMINATION TIME WAS SLIGHTLY LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402409 ↗
• MalfunctionDec 9, 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 ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT DIFFICULTY SWALLOWING PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST AS IT WAS BEING FILLED. 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763855 ↗
• MalfunctionDec 3, 2025Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  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) PROCEDURE TO TREAT JAUNDICE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE BALLOON WAS SLOWLY PRESSURIZED, IT WAS FOUND THAT THE BALLOON WAS RUPTURED 3 ATM (12 MM). IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. ADDITIONALLY, A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED AN INFLATED BALLOON WITH IRREGULAR SHAPE. 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 23708729 ↗
• MalfunctionMar 20, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE BALLOON WAS PLACED IN THE ESOPHAGUS, THE TECH TRIED TO INFLATE IT, BUT IT WOULD START TO LOSE PRESSURE INSTEAD OF FULLY GETTING TO THE LARGEST SIZE. THEY TOOK IT OUT OF THE PATIENT AND OBSERVED THAT IT HAD A SMALL PINHOLE LEAK. 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 21658256 ↗
• MalfunctionAug 7, 2024Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PRO WIREGUIDED DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE INFLATING THE BALLOON INSIDE THE PATIENT'S ESOPHAGUS, THE BALLOON BURST. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE PRO WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE PRO WIREGUIDED DILATATION 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 19935212 ↗
• MalfunctionAug 7, 2024Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PRO WIREGUIDED DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE INFLATING THE BALLOON INSIDE THE PATIENT'S ESOPHAGUS, THE BALLOON BURST. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE PRO WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE PRO WIREGUIDED DILATATION 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 19935165 ↗
• MalfunctionApr 16, 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 19118178 ↗
• MalfunctionJan 9, 2024Burst 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 DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST AT 12 MM DURING AN ATTEMPT AT THE FIRST DILATION OF THE DUODENUM. THE BALLOON REMAINED ATTACHED AND INTACT AND WAS ABLE TO BE PULLED OUT THROUGH THE SCOPE. 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 18480361 ↗
• MalfunctionDec 22, 2023Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS BEING PREPARED FOR USE IN THE ESOPHAGUS DURING A DILATATION OF ESOPHAGUS PROCEDURE TO BE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE NURSE UNPACKED THE BALLOON AND PRE-INJECTED LIQUID FOR EXAMINATION. THE BALLOON WAS FOUND TO LEAK LIQUID AT THE JUNCTION BETWEEN THE FRONT END OF THE BALLOON AND THE CATHETER, AND THE BALLOON COULD NOT BE FULLY INFLATED. 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. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387291 ↗
• MalfunctionJul 7, 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 DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2023. DURING PROCEDURE, THE BALLOON BURST AT 15MM DURING INFLATION. 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 CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283571 ↗
• MalfunctionMar 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 IN THE BILIARY TRACT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST AT 9ATM. 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 CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542727 ↗
• MalfunctionFeb 22, 2023Burst 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 A COMMON BILE DUCT (CBD) STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE BALLOON BURST OUTSIDE THE PATIENT BODY WHILE PREPARING FOR THE PROCEDURE. 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 CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417685 ↗
• MalfunctionDec 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, WHEN THEY INSERTED THE SOLUTION, IT TURNS WHITE THAT OCCLUDES AND BLURR THE VIEW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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 15942303 ↗
• MalfunctionDec 8, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) . DURING THE PROCEDURE, THE BALLOON LEAKED. THE DEVICE WAS REMOVED FROM THE ENDOSCOPE AND A TINY HOLE WAS DISCOVERED. THE CUSTOMER STATED THERE WERE NO SHARP OBJECTS CLOSE TO THE BALLOON AT ANY TIME. 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 15941088 ↗
• MalfunctionNov 22, 2022Burst 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) 2022.IT WAS STATED THAT THE BALLOON BURST. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENTTHERE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15846082 ↗
• MalfunctionNov 2, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE PROXIMAL ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, A LEAK WAS DISCOVERED AT THE DISTAL TIP OF THE BALLOON AND IT COULD NOT BE FULLY INFLATED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE 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 15718930 ↗
• MalfunctionJul 31, 2022Inflation Problem; Material Rupture; Use of Device Problem; Inflation Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT BE INFLATED. 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 CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS OF BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136892 ↗
• MalfunctionJul 11, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE THERE WAS HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME MODEL. 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 14977198 ↗
• MalfunctionFeb 15, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST WHILE CANNULATING. THE PROCEDURE IS 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 13534275 ↗
• MalfunctionNov 8, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON PRESSURE COULD NOT BE REACHED AND WATER WAS LEAKING THROUGH HOLE IN BALLOON. ADDITIONAL CLARIFICATION TO DETERMINE THE SIZE/NATURE OF THE HOLE HAS NOT BEEN PROVIDED, SO THE REPORTED EVENT WILL BE CONSIDERED A PINHOLE. THE PROCEDURE IS 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 12771707 ↗
• MalfunctionAug 20, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS LEAKING WATER AND IT COULD NOT BE INFLATED. 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 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 BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350478 ↗
• MalfunctionJun 2, 2021Material Puncture/Hole; Material Puncture/Hole

  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) PROCEDURE PERFORMED ON MAY 6, 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAD A VISIBLE HOLE. ADDITIONAL CLARIFICATION TO DETERMINE THE SIZE/NATURE OF THE HOLE HAS NOT BEEN PROVIDED, SO THE REPORTED EVENT WILL BE CONSIDERED A PINHOLE. 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 CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919175 ↗
• MalfunctionMay 24, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  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) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THIS BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873401 ↗