CRE™ PRO M00558620Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729797500), received between Sep 18, 2018 and Sep 30, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953785 ↗
• MalfunctionJul 12, 2026Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS BEING PREPARED TO BE USED THE PYLORUS DURING AN ENDOSCOPIC BALLOON DILATATION PROCEDURE FOR BENIGN PYLORIC STENOSIS PERFORMED ON (B)(6) 2026. DURING PREPARATION OUTSIDE THE PATIENT, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH CRE PRO WIREGUIDED DASE DILATATION BALLOON. 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 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 25791410 ↗
• MalfunctionApr 24, 2026Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS INTENDED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2026. PRIOR TO THE PROCEDURE, THE SEAL OF THE OUTER PACKAGE WAS NOTICED TO BE BROKEN. 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 24987494 ↗
• MalfunctionApr 17, 2026Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO A JAGWIRE REVOLUTION, TRUETOME 39, TWO TRAPEZOID RX LITHOTRIPTER BASKETS, AND CRE PRO WIREGUIDED DILATATION BALLOON USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION, TRUETOME 39, TWO TRAPEZOID RX LITHOTRIPTER BASKETS, AND CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND CBD STONE REMOVAL PROCEDURE TO TREAT JAUNDICE AND CBD STONE PERFORMED ON MARCH 23, 2026. DURING THE PROCEDURE, AFTER THE STONE WAS CAPTURED, THE BASKET COULD NOT BE PULLED THROUGH THE PAPILLA. THE TRAPEZOID RX BASKET WAS THEN CONNECTED TO AN ALLIANCE HANDLE TO PERFORM LITHOTRIPSY. DURING LITHOTRIPSY, THE BASKET FRACTURED AT THE HANDLE END, AND THE SAFETY RELEASE MECHANISM DID NOT ACTIVATE TO ALLOW RELEASE OF THE STONE FROM THE BASKET. THE PHYSICIAN THEN PERFORMED ANOTHER CRE DILATION, BUT THE CRE BALLOON DEVELOPED A SMALL RUPTURE DURING INFLATION. FOLLOWING THE RUPTURE OF THE CRE BALLOON, THE PHYSICIAN ATTEMPTED A PARTIAL PAPILLOTOMY USING A TRUETOME. HOWEVER, THE CUTTING EFFICIENCY WAS POOR, POSSIBLY DUE TO INTERFERENCE FROM A CBD STO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918058 ↗
• MalfunctionFeb 13, 2026Burst Container or Vessel; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT A TUMOR PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON USE. IT WAS REPORTED THAT NO PIECE 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 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 24331965 ↗
• MalfunctionApr 10, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY DUCT DURING A BILIARY DUCT 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 PRO 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 21818962 ↗
• MalfunctionJan 8, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST WHEN IT WAS INFLATED TO 3 ATM, 10 MM DIAMETER. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 21108412 ↗
• MalfunctionOct 18, 2024Inflation Problem; Difficult to Remove; Failure to Deflate; Inflation Problem; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE NURSE INFLATED THE BALLOON TO 11 AND THEN DEFLATED. THE BALLOON WAS PULLED BACK INTO THE SCOPE JUST A LITTLE AND THEN PUSHED OUT TO INFLATE TO 12 HOWEVER IT WOULD NOT INFLATE BUT THE GAUGE ON THE SYRINGE WAS MOVING AS IF IT WAS BEING PUSHED OUT OF THE SYRINGE. SINCE THE BALLOON WASN'T INFLATING THE PHYSICIAN WENT TO PULL BACK THE BALLOON AND REALIZED THERE WAS STILL SOME WATER IN THE BALLOON, BUT THE NURSE WAS NOT ABLE TO DEFLATE THE BALLOON TO REMOVE THE WATER. THE SCOPE WAS REMOVED FROM THE PATIENT AND THE BALLOON WAS THEN CUT. THE PROCEDURE HAD ALREADY BEEN COMPLETED SUCCESSFULLY USING 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 20487257 ↗
• MalfunctionJul 8, 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 PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE CUSTOMER REPORTED THAT THERE WAS STONE IN THE AREA OF DILATATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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. THE IFU ALSO INDICATES THAT THIS BALLOON SHOULD BE INFLATED WITH A LIQUID MEDIUM. HOWEVER, THE CUSTOMER REPORTED THAT THE BALLOON WAS INFLATED WITH AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697403 ↗
• MalfunctionApr 16, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT THE BALLOON BURST. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 19122316 ↗
• MalfunctionJan 11, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A BILIARY 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 18494903 ↗
• MalfunctionDec 12, 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 PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE BALLOON BURST AT 3 ATM. 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 18314273 ↗
• MalfunctionAug 9, 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 PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CRE BALLOON RUPTURED AT 10 MM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 17490730 ↗
• MalfunctionApr 25, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) BALLOON 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 COMPLETED WITH ANOTHER CRE PRO 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 16807546 ↗
• MalfunctionApr 4, 2023Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIRE GUIDED DILATATION BALLOON WAS UNPACKAGED FOR USE IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION OUTSIDE THE PATIENT, IT WAS FOUND THAT THE PRODUCT PACKAGE WAS DAMAGED AND IT WAS UNKNOWN IF STERILIZATION WAS COMPROMISED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16677972 ↗
• MalfunctionNov 22, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS STATED THAT 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 CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846019 ↗
• MalfunctionOct 27, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE BILIARY STRICTURE DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 12704743 ↗
• MalfunctionAug 2, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS LEAKING WHEN INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON PINHOLES. 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 12264044 ↗
• MalfunctionJul 21, 2021Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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 12204522 ↗
• MalfunctionJun 25, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT STONE DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CONTRAST MEDIA WAS LEAKING FROM THE BALLOON AND IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER A CRE PRO 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 12071284 ↗
• MalfunctionJun 25, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CONTRAST MEDIA WAS LEAKING FROM THE BALLOON AND IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER A CRE PRO 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 12071280 ↗
• MalfunctionMar 25, 2021Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE AMPULA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS TORN AND THE CONTRAST MEDIUM WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11568391 ↗
• MalfunctionDec 23, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO 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 THAT THE BALLOON HAD A SMALL HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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; No Consequences Or Impact To Patient

  MAUDE report 11064335 ↗
• MalfunctionDec 11, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) AND ENDOSCOPIC BALLOON SPHINCTEROPLASTY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INJECTED WITH CONTRAST; HOWEVER, IT WAS NOTICED THAT THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 10992489 ↗
• MalfunctionDec 9, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO 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, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON WAS LEAKING. IT WAS NOTED THAT THE BALLOON HAD BEEN PRE-TESTED PRIOR TO USE IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THIS BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10977452 ↗