CRE Wireguided M00558480Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729339410), received between Nov 7, 2017 and Sep 23, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Open, Classified

   Potential sterile breach of the pouches in which devices are packaged.

   Z-2635-2026 · Root cause: Package design/selection · FDA record ↗

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.

• MalfunctionSep 23, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873587 ↗
• MalfunctionSep 22, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859404 ↗
• MalfunctionSep 22, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859317 ↗
• MalfunctionFeb 16, 2026Difficult to Remove; Failure to Deflate

  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 TO TREAT NARROWING OF ESOPHAGUS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE THIRD BALLOON SUCCESSFULLY PASSED THROUGH THE COLONOSCOPE AND ENABLED DILATION; HOWEVER, IT COULD NOT BE RETRIEVED THROUGH THE WORKING CHANNEL AFTER FULL DEFLATION. THE PHYSICIAN CUT THE BALLOON TO ALLOW COMPLETE EVACUATION OF FLUID AND AIR, ENABLING SAFE REMOVAL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345012 ↗
• MalfunctionJul 4, 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 BILIARY DUCT DURING A BILIARY 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 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 22406295 ↗
• MalfunctionSep 17, 2024Burst 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 WIREGUIDED DILATATION BALLOON WAS BEING PREPARED FOR USE IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE CRE BALLOON RUPTURED. 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. 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 20237354 ↗
• MalfunctionApr 12, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIRE GUIDED DILATATION BALLOON WAS BEING PREPARED FOR USE IN A COLONOSCOPY PROCEDURE TO BE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE CRE BALLOON WAS RECEIVED, DAMAGE TO THE PACKAGING WAS NOTICED AND A HOLE WAS PRESENT IN THE PACKAGING. A PHOTO OF THE DEVICE PACKAGING WAS PROVIDED BY THE CUSTOMER AND SHOWS THAT THE STERILE POUCH OF THE DEVICE PACKAGING HAD MULTIPLE HOLES. THE PRODUCT WAS NOT USED IN ANY PROCEDURE. IT WAS REPORTED THAT THE INITIAL COLONOSCOPY PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER CRE WIRE GUIDED DILATATION BALLOON. 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 19101842 ↗
• MalfunctionJan 10, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A DILATION ON AN ESOPHAGEAL STRICTURE PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE CRE BALLOON WAS INFLATED AND WENT THROUGH DIFFERENT PRESSURES AND TIME WAITING PERIODS. WHEN THEY REACHED 4.5 ATM THE BALLOON BURST WITH THE CONTRAST LEAKING OUT. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT AND CONFIRMED THAT THERE WERE STAPLES IN THE AREA OF DILATATION. 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 18490044 ↗
• MalfunctionNov 30, 2023Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS BEING PREPARED FOR USE IN A PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE TECHNICIAN FOUND A HOLE IN THE BALLOON UPON ATTEMPTED INFLATION PRIOR TO INSERTING THE BALLOON IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RE WIREGUIDED 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 OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242234 ↗
• MalfunctionOct 4, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. UPON RECEIPT, THE PRODUCTS WERE DAMAGED. THE CARDBOARD BOX WAS FINE, NOT DENTED OR ANYTHING. HOWEVER, THE ALUMINUM POUCH WAS PERFORATED WITH HOLES, COMPROMISING THE STERILE BARRIER. THE PRODUCT WAS NOT USED IN A PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869737 ↗
• MalfunctionOct 4, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. UPON RECEIPT, THE PRODUCTS WERE DAMAGED. THE CARDBOARD BOX WAS FINE, NOT DENTED OR ANYTHING. HOWEVER, THE ALUMINUM POUCH WAS PERFORATED WITH HOLES, COMPROMISING THE STERILE BARRIER. THE PRODUCT WAS NOT USED IN A PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869639 ↗
• MalfunctionOct 4, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. UPON RECEIPT, THE PRODUCTS WERE DAMAGED. THE CARDBOARD BOX WAS FINE, NOT DENTED OR ANYTHING. HOWEVER, THE ALUMINUM POUCH WAS PERFORATED WITH HOLES, COMPROMISING THE STERILE BARRIER. THE PRODUCT WAS NOT USED IN A PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869624 ↗
• MalfunctionMar 20, 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 BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGE AND PLACED THE CATHETER THROUGH THE ENDOSCOPE. HOWEVER, THE BALLOON BURST AT A DIAMETER OF 8MM DURING DILATION. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576661 ↗
• MalfunctionFeb 9, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED TO DILATE THE COLON NEAR THE ANASTOMOSIS SITE DURING A COLONOSCOPY PROCEDURE PERFORMED ON JANUARY 19, 2023. DURING THE PROCEDURE, THE BALLOON POPPED BEFORE IT WAS COMPLETELY INFLATED. THE BALLOON WAS COMPLETELY RECOVERED FROM THE PATIENT. THE PHYSICIAN NOTED THE POSSIBILITY OF A STAPLE SNAGGING THE BALLOON DURING INFLATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED FEBRUARY 09, 2023*** THE CUSTOMER REPORTED THE ISSUE WAS CAUSED BY A STAPLE BEING SHARP ON ONE EDGE AND NOT A MALFUNCTION OF THE BALLOON. THERE WAS NO INJURY TO THE PATIENT AND THE BALLOON WAS FULLY RETRIEVED ON INSPECTION AFTER THE PROCEDURE. THE PHYSICIAN REPORTS THAT HE FULLY BELIEVES THE ISSUE WAS DUE TO THE STAPLE, WHICH WAS REMOVED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335658 ↗
• MalfunctionJul 25, 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 COLON DURING A COLONIC DILATATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON BURST WHILE BEING INFLATED. 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 15099040 ↗
• MalfunctionApr 27, 2022Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS TO BE USED DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON WAS LEAKING 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. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218878 ↗
• MalfunctionAug 16, 2021Material Puncture/Hole; Material Puncture/Hole

  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) WTH STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON COULD NOT BE INFLATED. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT AND CHECKED AND THERE WAS 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 12323727 ↗
• MalfunctionJul 22, 2021Burst 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 ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON BURST INSIDE THE PATIENT. REPORTEDLY, THE PATIENT EXPERIENCED ANXIETY DURING THE PROCEDURE. THERE WAS NO REPORTED TREATMENT FOR THE ANXIETY. 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: Anxiety

  MAUDE report 12214395 ↗
• MalfunctionJun 7, 2021Burst Container or Vessel; Inflation Problem; Use of Device Problem; Burst Container or Vessel; Inflation Problem; Use of Device Problem

  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) 2021. DURING PREPARATION, THE BALLOON WAS INFLATED OUTSIDE THE PATIENT FOR TESTING; HOWEVER, THE BALLOON WAS OVERINFLATED AND ULTIMATELY BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THE BALLOON SHOULD NOT BE PRE-INFLATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953530 ↗
• MalfunctionApr 15, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE AMPULLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SPHINCTEROPLASTY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, A HOLE WAS VISIBLLY NOTED AT THE ROUNDED SHOULDER OF THE BALLOON NEAR TO THE TIP, CAUSING THE BALLOON TO LEAK. 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 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 11675542 ↗
• MalfunctionMar 15, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE PYLORUS DURING AN ENDOSCOPIC DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON BURST MID-PROCEDURE WHILE BEING INFLATED. 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 11488050 ↗
• MalfunctionNov 9, 2020Material 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 ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WOULD NOT HOLD PRESSURE DUE TO A HOLE OBSERVED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10812879 ↗
• MalfunctionNov 3, 2020Burst Container or Vessel; Appropriate Device Problem Term/Code Not Available; Burst Container or Vessel; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE DESCENDING COLON DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, THE BALLOON RUPTURED WHEN INFLATED TO 6 ATM. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS THEN ABORTED AS ANOTHER OF THE SAME DEVICE WAS UNAVAILABLE. 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 Consequences Or Impact To Patient

  MAUDE report 10781530 ↗
• MalfunctionOct 13, 2020Material Puncture/Hole; Material Puncture/Hole

  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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THERE WAS A HOLE IN THE MID SECTION OF THE BALLOON. 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. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10672614 ↗
• MalfunctionSep 22, 2020Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE WIREGUIDED DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE WIREGUIDED DILATATION BALLOON WERE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON DEFLATED WHILE ATTEMPTING TO BE INFLATED. THE SAME ISSUE OCCURRED WITH THE SECOND CRE WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS COMPLETED ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD BURST; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567600 ↗