CRE Wireguided M00558440Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729339373), received between Oct 11, 2018 and Jul 14, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (15 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPY WITH ESOPHAGEAL DILATATION PROCEDURE TO TREAT DYSPHAGIA AND BENIGN STRICTURE IN ESOPHAGUS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, UPON INFLATING THE CRE BALLOON, IT WAS DISCOVERED THAT THE BALLOON WAS LEAKING FLUID. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25821010 ↗
• MalfunctionFeb 4, 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 WIREGUIDED DILATATION BALLOON WAS USED IN THE DUODENAL PAPILLA DURING A BILIARY DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON BURST AT 20MM WHEN CONTRAST AGENT WAS INJECTED INTO THE BALLOON. THE CUSTOMER STATED 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'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259766 ↗
• MalfunctionDec 24, 2025Leak/Splash; Deformation Due to Compressive Stress; Leak/Splash; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CATHETER KINKED, WHICH RESULTED IN BALLOON LEAKAGE. THE PROCEDURE WAS COMPLETED 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 23886223 ↗
• MalfunctionDec 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT DYSPHAGIA PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON IMMEDIATELY STARTS LEAKING ONCE REACHED 18 MM DUE TO A SMALL PUNCTURE HOLE. A PHOTO OF THE COMPLAINT DEVICE INSIDE THE PATIENT WAS PROVIDED AND SHOWED THE BALLOON WITH A PINHOLE LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 23884411 ↗
• MalfunctionDec 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT A LEAK WAS NOTED ON MULTIPLE SPOTS AT THE SHOULDER OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE ANATOMY LOCATION IS UNKNOWN AND IS BEING REPORTED AS THE LEAK MAY HAVE OCCURRED IN THE ESOPHAGUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722600 ↗
• MalfunctionDec 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT A LEAK WAS NOTED ON MULTIPLE SPOTS AT THE SHOULDER OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE ANATOMY LOCATION IS UNKNOWN AND IS BEING REPORTED AS THE LEAK MAY HAVE OCCURRED IN THE ESOPHAGUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716948 ↗
• MalfunctionNov 14, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) DILATION PROCEDURE TO TREAT EGD STRICTURES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WATER WAS LEAKING FROM BALLOON SHOULDER THROUGH PUNCTURE HOLE. THE ANATOMY LOCATION OF THE PROCEDURE IS UNKNOWN AND IS BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 23556352 ↗
• MalfunctionSep 10, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) DILATION PROCEDURE TO TREAT DYSPLASIA PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON HAD MULTIPLE LEAKS WHEN ATTEMPTING TO INFLATE TO 18 MM. UPON TAKING IT OUT, AFTER IT WOULD NOT INFLATE, AND AFTER BEING INFLATED AGAIN, MULTIPLE HOLES THAT WERE LEAKING WERE NOTED. IT WAS REPORTED THAT 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022908 ↗
• MalfunctionAug 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A GASTROSCOPY WITH ESOPHAGEAL DILATATION PROCEDURE TO TREAT A BENIGN STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON PRESENTED A LEAK WHILE INFLATED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 3, 2025** IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919895 ↗
• MalfunctionJul 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) DILATION PROCEDURE TO TREAT SWALLOWING DIFFICULTIES PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, UPON INFLATION OF THE BALLOON, A WATER LEAK WAS NOTED. THE BALLOON WAS UNABLE TO PROPERLY INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 22670354 ↗
• MalfunctionJan 10, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE BALLOON BURST WHEN TRYING TO INFLATE TO 20MM DIAMETER. THE BALLOON HAD ALREADY BEEN INFLATED TO 18MM AND 19MM SUCCESSFULLY. IT WAS REPORTED THAT NO PIECES 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123787 ↗
• MalfunctionOct 3, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENOSIS DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON LEAKED. IT WAS REPORTED THAT THE BALLOON HAD A HOLE. 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 AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360082 ↗
• MalfunctionSep 6, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 20163953 ↗
• MalfunctionAug 26, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE GASTROINTESTINAL (GI) TRACT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON LEAKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED ANATOMY LOCATION OF THE PROCEDURE WAS NOT SPECIFIC AND IS BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072000 ↗
• MalfunctionAug 18, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING WITHDRAWAL OF THE PROCEDURE, THE SCOPE WAS OUT OF THE PATIENT'S MOUTH WHEN THE CATHETER BROKE AND THE BALLOON PORTION OF THE CATHETER DETACHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999332 ↗
• MalfunctionDec 12, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON WAS UNABLE TO INFLATE DUE TO A LEAK. THE CUSTOMER REPORTED THE BALLOON HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 18314405 ↗
• MalfunctionOct 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING A DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON WAS UNABLE TO BE INFLATED DUE TO A WATER LEAK FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 17968115 ↗
• MalfunctionOct 13, 2023Burst 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 WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENOSIS DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST AT 6 ATM WHEN THE DILATION PRESSURE WAS MAINTAINED. THE CUSTOMER STATED THAT NO PIECES 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 17936080 ↗
• MalfunctionMay 18, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE LARYNX DURING A DIRECT LARYNGOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON RUPTURED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955622 ↗
• MalfunctionApr 19, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON WAS PASSED THROUGH THE SCOPE AND POSITIONED IN THE CENTER OF THE STRICTURE. WHEN THE BALLOON WAS INFLATED, IT WAS NOTICED THAT THE BALLOON WAS NOT INFLATING, AND THE SALINE WAS LEAKING INTO THE PATIENT. THE BALLOON WAS REMOVED AND INSPECTED. IT WAS LEAKING FROM WHERE THE PROXIMAL PART OF THE BALLOON IS JOINED TO THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SMALLER SIZED CRE 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 16770434 ↗
• InjuryDec 21, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST AT 20MM WHICH IS 6 ATM OF PRESSURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT; HOWEVER, A SERIOUS INJURY AND REQUIRED INTERVENTION WAS NOTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 16029688 ↗
• MalfunctionNov 2, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716484 ↗
• MalfunctionAug 11, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION 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 BURST AT LESS THAN THE WORKING PRESSURE AND WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 15210416 ↗
• MalfunctionApr 13, 2022Leak/Splash; Material Puncture/Hole; Use of Device Problem; Leak/Splash; Material Puncture/Hole; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING ESOPHAGEAL PROCEDURE PERFORMED ON (B)(6)2022. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON WAS LEAKING LIQUID AFTER INJECTING THE LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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. 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 14107217 ↗
• MalfunctionMar 16, 2022Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS 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 WIREGUIDED DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS OF BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13780003 ↗