CRE Fixed Wire M00558350Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729202004), received between Feb 6, 2019 and Aug 20, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (24 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.

• MalfunctionAug 20, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360035 ↗
• MalfunctionApr 30, 2026Inflation Problem; Leak/Splash; Use of Device Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE FIXED WIRE DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) DILATION PROCEDURE TO TREAT ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 12 MM AND SUBSEQUENTLY TO 13.5 MM USING THE ALLIANCE II INFLATION DEVICE, WITH NO PROBLEMS REPORTED. WHEN INFLATION WAS INCREASED TO 15 MM, THE BALLOON WAS REPORTED TO NOT MAINTAIN THE TARGET PRESSURE AND WAS OBSERVED TO DECREASE BACK TO APPROXIMATELY 12 MM. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE FIXED WIRE DILATATION BALLOON. THE PHYSICIAN INFLATED THE BALLOON AS MUCH AS HE COULD AND COMPLETED THE PROCEDURE WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038801 ↗
• MalfunctionApr 25, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON BURST AT 8 ATM DURING INFLATION TO THE HIGHEST RATED PRESSURE. THE RUPTURE APPEARED TO OCCUR AT THE JUNCTION WHERE THE BALLOON ATTACHES TO THE CATHETER. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE FULL RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24991964 ↗
• MalfunctionApr 7, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. UPON RECEIPT OF THE SHIPMENT, IT WAS REPORTED THAT ONE DEVICE HAD A CUT IN THE PACKAGING. THE DEVICE WAS NOT USED IN A PROCEDURE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE PACKAGING TO BE CUT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796392 ↗
• MalfunctionMar 5, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE TO TREAT ESOPHAGEAL STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS LIGHTLY INFLATED ONCE AFTER PLACING IT AT THE AREA OF THE ESOPHAGUS THAT NEEDED DILATION. HOWEVER, THE BALLOON RUPTURED WHEN DEFLATION WAS PERFORMED TO ATTEMPT DILATION. THE EXACT PRESSURE WHEN THE BALLOON BURST WAS UNKNOWN, BUT IT WAS REPORTED THAT IT WAS LESS THAN 3ATM AFTER INFLATION. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527450 ↗
• MalfunctionNov 5, 2025Leak/Splash; Use of Device Problem; Deformation Due to Compressive Stress; Leak/Splash; Use of Device Problem; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT A BALLOON LEAKAGE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 BALLOON WAS PRE INFLATED PRIOR TO USE IN THE PATIENT. ***ADDITIONAL INFORMATION*** BASED ON THE GFE RESPONSE ON 04NOV2025 THAT THE CATHETER KINKED, SUPPLEMENT REPORT FOR CORRECTION WAS CREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473067 ↗
• MalfunctionOct 27, 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 FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE DISTAL ESOPHAGUS DURING A DILATION PROCEDURE TO TREAT ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST AT 11MM DURING BALLOON INFLATION. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390416 ↗
• MalfunctionSep 30, 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 FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STRICTURE DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23187020 ↗
• MalfunctionJun 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A GASTROINTESTINAL DILATION PROCEDURE TO TREAT ESOPHAGEAL STENOSIS. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, DILATION WAS UNABLE TO PERFORM PROPERLY, AND WHEN IT WAS CHECKED OUTSIDE THE PATIENT, A PINHOLE WAS FOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151151 ↗
• MalfunctionMay 7, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A BALLOON DILATATION 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 THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976449 ↗
• MalfunctionDec 27, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING DILATION PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED, THEY NOTICED A PIN HOLE LEAK IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029684 ↗
• MalfunctionDec 27, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING DILATION PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED, THEY NOTICED A PIN HOLE LEAK IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029675 ↗
• MalfunctionDec 27, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING DILATION PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED, THEY NOTICED A PIN HOLE LEAK IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029670 ↗
• MalfunctionOct 29, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF CRE FIXED WIRE DILATATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563255 ↗
• MalfunctionJun 28, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AFTER INFLATING THE BALLON TO 8 ATM DURING THE DILATATION, THE TECHNICIAN WAS NOT ABLE TO FULLY DEFLATE THE BALLOON. THEY HAD TO REMOVE THE ENDOSCOPE AND CUT THE BALLOON FROM THE TIP OF THE SCOPE TO REMOVE THE DEVICE. THE PROCEDURE HAD ALREADY BEEN COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632349 ↗
• MalfunctionApr 1, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE UPPER ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 10 MM AND 11 MM WITHOUT ANY PROBLEM, HOWEVER, WHEN IT WAS INFLATED TO 12 MM THE BALLOON BURST. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SAVARY DILATOR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015704 ↗
• MalfunctionMar 27, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST WHEN IT WAS INFLATED FROM 11 MM TO 12 MM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988730 ↗
• MalfunctionJan 10, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A DILATATION 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 ALREADY COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490269 ↗
• MalfunctionDec 12, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE DISTAL ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD)PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHILE INFLATING THE BALLOON, THE BALLOON BURST BEFORE IT REACHED 10 MM SIZE. A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWS THAT THE BALLOON WAS BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314489 ↗
• MalfunctionApr 24, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE COLON DURING A COLOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHILE ADVANCING THE BALLOON INTO AN ANASTOMOTIC STRICTURE, THE BALLOON WAS INFLATED AND IMMEDIATELY BURST AT 3 ATM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801656 ↗
• MalfunctionMar 8, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON POPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507806 ↗
• MalfunctionNov 29, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON POPPED DURING INFLATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15877445 ↗
• MalfunctionNov 21, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN A PROCEDURE ON (B)(6) 2022. 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. 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 15835555 ↗
• MalfunctionNov 16, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON BURST AT 12 ATM WHILE BEING INFLATED INSIDE THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAD A VERY NARROW STRICTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808347 ↗
• MalfunctionNov 14, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, BALLOON INFLATION WAS ATTEMPTED HOWEVER, IT COULD NOT BE INFLATED. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT THE BALLOON HAD RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794094 ↗