CRE Fixed Wire M00558360Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 08714729195986), received between Oct 27, 2017 and Jul 17, 2026 — classified as 2 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (47 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2026Burst Container or Vessel; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25851184 ↗
• MalfunctionJul 9, 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 FOR ESOPHAGEAL STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, THE BALLOON WAS ADVANCED FROM THE LOWEST TO THE SECOND DILATION PRESSURE. AS THE PRESSURE APPROACHED 4 ATM AND THE DIAMETER REACHED APPROXIMATELY 13.5 MM, THE BALLOON BURST INSIDE THE PATIENTS ESOPHAGUS. NO PIECE OF 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 PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25773589 ↗
• MalfunctionMay 15, 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 ESOPHAGEAL DILATION PROCEDURE FOR ESOPHAGEAL STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191481 ↗
• MalfunctionMay 12, 2026Burst Container or Vessel; Detachment of Device or Device Component; 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 DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON RUPTURED DURING USE AND WAS UNABLE TO REACH FULL INFLATION PRESSURE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED SHOWS THE BALLOON WAS BURST AND THE BALLOON DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146049 ↗
• MalfunctionApr 27, 2026Use of Device Problem; 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) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE APPROPRIATELY. IT WAS REPORTED THAT THE DOCTOR REMOVED THE SCOPE AND THEN THE BALLOON WAS CUT AT THE TIP OF THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010722 ↗
• MalfunctionMar 25, 2026Burst 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 TO TREAT ESOPHAGEAL STRICTURE PERFORMED ON (B)(6), 2026. DURING THE PROCEDURE, THE BALLOON POPPED AND COULD NOT BE USED. IT WAS REPORTED THAT NO PART OF THE BALLOON DETACHED AND FELL 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683983 ↗
• MalfunctionJan 12, 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 AN ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON POPPED WHILE BEING INFLATED. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE BALLOON WAS THEN REMOVED FROM THE SCOPE, AND THE PROCEDURE WAS COMPLETED USING 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 24036735 ↗
• MalfunctionJan 9, 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 ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, BALLOON WAS INFLATED TO 12MM SUCCESSFULLY. WHEN THEY WENT TO INFLATE IT TO 13.5MM, THE BALLOON BURST. 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. IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030664 ↗
• MalfunctionJan 7, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A BALLOON DILATION PROCEDURE TO TREAT ESOPHAGEAL STRICTURE, PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE PRESSURE INCREASED FROM 6.5 ATM TO 7ATM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991001 ↗
• MalfunctionJan 7, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A BALLOON DILATION PROCEDURE TO TREAT ESOPHAGEAL STRICTURE, PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE PRESSURE WAS BEING HELD AT 6 ATM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990205 ↗
• MalfunctionNov 13, 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 AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DILATION CATHETER BALLOON RUPTURED WHILE BEING INFLATED AT 15MM (8 ATM) PRIOR TO BEING INFLATED FOR 1 MINUTE AT 13.5MM (4.5 ATM). THE CATHETER WAS IMMEDIATELY WITHDRAWN FROM THE SCOPE, AND THE BALLOON CATHETER WAS INSPECTED AND WAS CONFIRMED TO HAVE BURST. THE ENDOSCOPIST WAS ABLE TO COMPLETE THE PROCEDURE WITH THE ORIGINAL 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 23544332 ↗
• MalfunctionNov 5, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  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 PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST JUST BEFORE 15 MM WERE REACHED AND THE WATER LEAKED THROUGH THE DISTAL END OF BALLOON. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 23473180 ↗
• 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 RECEIVED NOVEMBER 4, 2025. IT WAS REPORTED THAT THE CATHETER KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473068 ↗
• MalfunctionOct 17, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A DILATATION PROCEDURE TO TREAT STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. IT WAS REPORTED THAT THE CUSTOMER NOTICED A HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320216 ↗
• MalfunctionOct 3, 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 STENOSIS DILATION PROCEDURE PERFORMED FOR THE TREATMENT OF ESOPHAGEAL CANCER ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 15MM USING AN INDEFLATOR AT 7 ATM, BUT THE BALLOON 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 23215979 ↗
• MalfunctionJul 18, 2025Leak/Splash; Leak/Splash

  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, THE BALLOON WAS ONLY ABLE TO INFLATE TO 2-3 ATM, AND WHEN IT WAS CHECKED, IT WAS FOUND TO BE LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE 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 22543804 ↗
• MalfunctionFeb 13, 2025Leak/Splash; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOONS IMMEDIATELY DEFLATED WHEN INFLATED. THEY WOULD NOT HOLD FLUID TO DILATE APPROPRIATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THE TYPE OF PROCEDURE AND ANATOMY LOCATION OF THE PROCEDURE ARE 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 21379098 ↗
• MalfunctionFeb 13, 2025Leak/Splash; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOONS IMMEDIATELY DEFLATED WHEN INFLATED. THEY WOULD NOT HOLD FLUID TO DILATE APPROPRIATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THE TYPE OF PROCEDURE AND ANATOMY LOCATION OF THE PROCEDURE ARE 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 21379091 ↗
• MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN A PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE WAS INFLATED BY THE CLINICIAN AND NOTICED THAT THE CONTRAST WAS LEAKING FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A SECOND CRE FIXED WIRE DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE ANATOMY LOCATION AND PROCEDURE TYPE ARE 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 21294734 ↗
• MalfunctionJan 28, 2025Burst Container or Vessel; Burst 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. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE BALLOON BURST WHILE INFLATING TO SIZE 13.5MM. 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 21256470 ↗
• MalfunctionOct 9, 2024Burst Container or Vessel; Burst 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 GASTRIC DUODENAL STRICTURE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED TO 12 MM AND THEN 13.5 MM BUT ON ATTEMPTING TO GO TO 15 MM THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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 20407211 ↗
• MalfunctionSep 16, 2024Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  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 ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING WITHDRAWAL, THE DEVICE WOULD NOT EXIT THE SCOPE. IT FELT LIKE IT WAS STUCK. AFTER EXTENSIVE PULLING, THE BALLOON WAS FINALLY REMOVED. IT WAS REPORTED THAT THE BALLOON WAS PARTIALLY DEFLATED AND UPON REMOVAL, THERE WAS EXCESS BALLOON GATHERED AT THE BOTTOM OF THE BALLOON. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE FIXED WIRE DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD 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 20232537 ↗
• MalfunctionSep 4, 2024Material Puncture/Hole; Material Puncture/Hole

  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 ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED, WATER WAS LEAKING OUT. IT WAS REPORTED THAT THE BALLOON HAD A HOLE. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE FIXED WIRE DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD 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 20140751 ↗
• MalfunctionSep 4, 2024Material Puncture/Hole; Material Puncture/Hole

  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 ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED, WATER WAS LEAKING OUT. IT WAS REPORTED THAT THE BALLOON HAD A HOLE. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE FIXED WIRE DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD 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 20140750 ↗
• MalfunctionSep 3, 2024Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE 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 ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING WITHDRAWAL, THE BALLOON WOULD NOT DEFLATE SO IT HAD TO BE CUT FROM THE CATHETER TO REMOVE FROM THE SCOPE. THE SAME PROBLEM OCCURRED WITH THE SECOND AND THIRD CRE FIXED WIRE DILATATION 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 20128921 ↗