CRE Pulmonary M00550340Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729456223), received between May 29, 2019 and Apr 10, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Inflation Problem; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE LEFT MAIN BRONCHUS DURING A BRONCHOSCOPIC BRONCHIECTASIS PROCEDURE FOR STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON LEAKED LIQUID AND COULD NOT BE INFLATED. 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 24842023 ↗
• MalfunctionFeb 13, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE TRACHEA DURING AN AIRWAY STENOSIS DILATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FRONT END OF THE DEVICE WAS OBSERVED TO BE LEAKING WATER. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 24338864 ↗
• MalfunctionJan 15, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AIRWAY DURING A BRONCHOSCOPIC DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS LEAKING WATER. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 24079403 ↗
• MalfunctionDec 30, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN RIGHT MAIN BRONCHUS DURING AN ENDOSCOPIC DILATATION PROCEDURE OF TRACHEA TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, FOLLOWING ABLATION OF THE RIGHT MAIN BRONCHUS, THE BALLOON BURST UNEXPECTEDLY WHEN INFLATED TO 3 ATM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931266 ↗
• MalfunctionDec 19, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PULMONARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS INSERTED UP TO THE STENOSIS PART AND INFLATED ONCE. HOWEVER, IT COULD NOT BE INFLATED DURING THE SECOND ATTEMPT. THE PROCEDURE WAS PERFORMED AGAIN USING ANOTHER DEVICE FROM THE SAME LOT NUMBER; HOWEVER, THE SAME PROBLEM OCCURRED, AND INFLATION WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED WITH THE THIRD CRE PULMONARY DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A BALLOON PINHOLE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857397 ↗
• MalfunctionDec 17, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PULMONARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS INSERTED UP TO THE STENOSIS PART AND INFLATED ONCE. HOWEVER, IT COULD NOT BE INFLATED DURING THE SECOND ATTEMPT. THE PROCEDURE WAS PERFORMED AGAIN USING ANOTHER DEVICE FROM THE SAME LOT NUMBER; HOWEVER, THE SAME PROBLEM OCCURRED, AND INFLATION WAS NOT POSSIBLE. THE PROCEDURE WAS COMPLETED WITH THE THIRD CRE PULMONARY DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A BALLOON PINHOLE. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834586 ↗
• MalfunctionNov 24, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LEFT UPPER LOBE OF THE LUNGS DURING A BALLOON DILATATION PROCEDURE TO TREAT BRONCHIAL STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A LEAK WAS FOUND AT THE CONNECTION BETWEEN THE PURPLE PLASTIC AT THE PROXIMAL END OF THE BALLOON AND THE BALLOON. IT WAS REPORTED THAT A VISIBLE PINHOLE WAS NOTED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOW A WATER LEAK AT THE PURPLE PLASTIC ON THE PROXIMAL END OF THE 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 23640189 ↗
• MalfunctionAug 13, 2025Leak/Splash; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PULMONARY DILATATION BALLOON USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BRONCHUS DURING AN AIRWAY DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE HAD A LEAK. A SECOND CRE PULMONARY DILATATION BALLOON WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE PULMONARY 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 22800926 ↗
• MalfunctionAug 13, 2025Leak/Splash; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PULMONARY DILATATION BALLOON USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BRONCHUS DURING AN AIRWAY DILATION PROCEDURE PERFORMED FOR THE TREATMENT OF AIRWAY DILATION ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE HAD A LEAK. A SECOND CRE PULMONARY DILATATION BALLOON WAS USED; HOWEVER, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE PULMONARY 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 22800922 ↗
• MalfunctionMay 12, 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 PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE SUBGLOTTIC AIRWAY DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED TO THE SUBGLOTTIC TRACHEA STENOSIS SITE, AND THE DILATATION WAS INEFFECTIVE AFTER BEING FILLED WITH WATER, RESULTING IN DILATATION FAILURE. IT WAS REPORTED THE BALLOON WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 22003863 ↗
• MalfunctionMar 31, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE RIGHT MAIN TRACHEA DURING A TRANSBRONCHOSCOPIC BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, AFTER UNPACKING, THE BALLOON DILATATION CATHETER ENTERED THE TRACHEAL STENOSIS POSITION THROUGH THE WORKING CHANNEL OF THE FIBEROPTIC BRONCHOSCOPE, AND IT WAS FOUND THAT THE DEVICE LEAKED WATER AFTER DILATATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 21731418 ↗
• MalfunctionJan 28, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON POPPED INSIDE THE PATIENT WHILE DILATING THE AIRWAY. THE BALLOON WAS FILLED WITH A 50/50 MIXTURE OF OMNIPAQUE 350 MGL/ML AND NORMAL SALINE. NO FURTHER EVENT INFORMATION WAS PROVIDED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256504 ↗
• MalfunctionJun 18, 2024Burst Container or Vessel; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AIRWAY VIA BRONCHOSCOPE DURING A FROZEN LUNG BIOPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE BALLOON BURST WHEN THE PRESSURE WAS APPLIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. 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. 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. ADDITIONAL INFORMATION RECEIVED ON JUNE 23, 2024. IT WAS REPORTED THAT THE BALLOON BURST WHEN THE PRESSURE WAS APPLIED AT 8ATM. ADDITIONALLY, IT WAS CONFIRMED THAT THE BALLOON WAS LEAKING LIQUID WHEN INFLATED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558509 ↗
• MalfunctionMay 22, 2024Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE RIGHT PRIMARY BRONCHUS DURING A BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON COULD NOT EXPAND NORMALLY AFTER ENTERING THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 PINHOLE WHEN USED IN THE PULMONARY ANATOMIES. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374763 ↗
• MalfunctionMar 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LUNGS DURING AN AIRWAY DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON IN THE AIRWAY AND SOON AFTER STARTING INFLATION, THE BALLOON WAS LEAKING AND COULD NOT BE INFLATED ANYMORE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871215 ↗
• MalfunctionFeb 6, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE AIR PASSAGE DURING AN AIRWAY DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 18650386 ↗
• MalfunctionDec 5, 2023Burst Container or Vessel; Component Missing; Burst Container or Vessel; Component Missing

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LEFT PRINCIPAL BRONCHUS DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. UPON UNPACKING OF THE DEVICE, IT WAS NOTICED THAT THE BALLOON PRESSURE LABEL WAS MISSING. 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 PULMONARY 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 18269378 ↗
• MalfunctionOct 10, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE BRONCHUS DURING A BRONCHOSCOPIC BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST AT 8 ATM, 12MM. THE CUSTOMER STATED THAT NO PIECES OF THE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905912 ↗
• MalfunctionJun 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE BRONCHIAL STENOSIS DURING THE BALLOON DILATION VIA FIBEROPTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON WAS LEAKING LIQUID WHEN THE DEVICE WAS PUT AT THE BRONCHIAL STENOSIS, AND THE LIQUID WAS APPLIED TO DILATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 17172411 ↗
• MalfunctionJun 7, 2023Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LUNG DURING THE DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PREPARATION, AFTER OPENING THE ACCESSORIES, WAS TRYING TO CHECK WHETHER IT IS DILATING OR NOT. OBSERVED THAT SOME LEAK FROM THE DISTAL END OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. 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 THE BALLOON WAS PRE-INFLATED PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080490 ↗
• MalfunctionDec 8, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE TRACHEA DURING A BALLOON TRACHEA DILATATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PRESSURE DID NOT CONTINUE TO RISE AFTER BEING CONNECTED TO THE PRESSURE GUN FOR INFLATION. REPORTEDLY, SALINE IN THE BALLOON LEAKED OUT FROM THE SIDE. THE DEVICE WAS RETRIEVED FROM THE PATIENT AND HOLES WERE NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 15944960 ↗
• MalfunctionNov 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE BRONCHUS DURING AN ENDOTRACHEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WAS LEAKING AND COULD NOT HOLD ENOUGH PRESSURE TO MAINTAIN SUPPORTING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO 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 15794581 ↗
• MalfunctionJun 29, 2022Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE WEASAND DURING A BALLOON DILATATION UNDER BRONCHOSCOPE PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. 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 HAVE BEEN REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859846 ↗
• MalfunctionOct 26, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LEFT LOWER LOBE DURING A BRONCHOSCOPY WITH DILATION AND POSSIBLE STENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS KINKING AND THE CATHETER WAS STARTING TO KINK AFTER GOING DOWN THE BRONCHOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734658 ↗
• MalfunctionFeb 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE BRONCHUS DURING AN ENDOSCOPIC PULMONARY DILATATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT STARTED TO BLEED DURING THE FIRST DILATION. THE BALLOON WAS REMOVED IN ORDER TO PERFORM BLEEDING MANAGEMENT IN THE FORM OF ENERGY COAGULATION. THE BALLOON WAS INTRODUCED AGAIN BUT WAS UNABLE TO PASS THROUGH THE WORKING CHANNEL OF THE SCOPE, AND IT WAS OBSERVED THAT THE DISTAL TIP OF THE CATHETER WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON DEVICE. PER THE PHYSICIAN ASSESSMENT, THE BLEEDING WAS DUE TO THE VASCULAR TISSUE, NOT DUE TO THE BALLOON. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9683143 ↗