MaxForce™ M00567340Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729097051), received between Sep 10, 2018 and Mar 30, 2023 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (29 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.

• MalfunctionMar 30, 2023Material Puncture/Hole

  WHILE TRYING TO DILATE THE PANCREATIC DUCT WITH MAXFORCE BILIARY 4MM X 4CM BALLOON DILATION CATHETER WAS NOTED THE BALLOON HAD A HOLE.

  Patient problems: Insufficient Information

  MAUDE report 16642960 ↗
• MalfunctionJun 1, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL PART OF THE BALLOON WAS LEAKING DUE TO A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON OF A DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912938 ↗
• MalfunctionFeb 10, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306888 ↗
• MalfunctionDec 16, 2020Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS INFLATED OUTSIDE THE PATIENT FOR TESTING; HOWEVER, THE BALLOON WOULD NOT INFLATE DUE TO A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11021719 ↗
• MalfunctionDec 3, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY 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 NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10941383 ↗
• MalfunctionNov 9, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATION BALLOON WAS USED IN A DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE BALLOON BURST WHEN INFLATED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10812787 ↗
• MalfunctionNov 5, 2020Material Puncture/Hole; Material Puncture/Hole

  BOSTON SCIENTIFIC CORPORATION RECEIVED AN UNAUTHORIZED RETURN OF A MAXFORCE BILIARY DILATATION BALLOON. IT WAS FOUND THAT THE BALLOON HAD A PINHOLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10791367 ↗
• MalfunctionSep 30, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A BILIARY DILATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, A SMALL HOLE WAS OBSERVED IN THE BALLOON SURFACE WHEN INFLATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10609678 ↗
• MalfunctionSep 28, 2020Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOONS WERE USED DURING A BILE DUCT DILATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE DUE TO A LEAK. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAVE PINHOLES; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10595312 ↗
• MalfunctionSep 28, 2020Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOONS WERE USED DURING A BILE DUCT DILATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE DUE TO A LEAK. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY 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 10594722 ↗
• MalfunctionAug 19, 2020Burst Container or Vessel; Obstruction of Flow; Material Deformation; Burst Container or Vessel; Obstruction of Flow; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOONS WERE USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON POPPED. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BILIARY DILATATION BALLOON. IT WAS NOTED THAT THE BALLOONS POPPED AT 4MM. THE PROCEDURE WAS COMPLETED WITH A HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10425177 ↗
• MalfunctionAug 19, 2020Burst Container or Vessel; Material Puncture/Hole; Obstruction of Flow; Material Deformation; Burst Container or Vessel; Material Puncture/Hole; Obstruction of Flow; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOONS WERE USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON POPPED. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BILIARY DILATATION BALLOON. IT WAS NOTED THAT THE BALLOONS POPPED AT 4MM. THE PROCEDURE WAS COMPLETED WITH A HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10425129 ↗
• MalfunctionApr 27, 2020Inflation Problem; Obstruction of Flow; Inflation Problem; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILE DUCT 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 COULD NOT BE INFLATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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, GOOD AND FINE. 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 10002682 ↗
• MalfunctionApr 27, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE MIDDLE PART OF THE DUCTUS CHOLEDOCHUS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON SUDDENLY LOST PRESSURE, AND IT SEEMED LIKE THE BALLOON BURST. THE DEVICE WAS THEN REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000837 ↗
• MalfunctionApr 23, 2020Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. THE ANATOMY LOCATION OF THE PROCEDURE WAS THE BILE DUCT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOONS WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS SUCCESSFULLY INFLATED TO ABOUT 6 TO 8 ATM; HOWEVER, THE BALLOON LOSS PRESSURE AND EVENTUALLY WOULD NOT INFLATE ANYMORE. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT AND ANOTHER MAXFORCE BALLOON WAS USED. THE SECOND BALLOON WAS INFLATED TO 2 ATM FOR TESTING PRIOR TO PROCEDURE AND THERE WERE NO ISSUES NOTED; HOWEVER, THE BALLOON WOULD NOT INFLATE WHEN INSIDE THE PATIENT. THE SECOND BALLOON WAS THEN REMOVED FROM THE PATIENT, AND LIQUID WAS NOTED COMING OUT OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD MAXFORCE BILIARY 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 FINE. INVESTIGATION RES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991085 ↗
• MalfunctionApr 23, 2020Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS SUCCESSFULLY INFLATED TO ABOUT 6 TO 8 AM; HOWEVER, THE BALLOON LOSS PRESSURE AND EVENTUALLY WOULD NOT INFLATE ANYMORE. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT AND ANOTHER MAXFORCE BALLOON WAS USED. THE SECOND BALLOON WAS INFLATED TO 2 ATM FOR TESTING PRIOR TO PROCEDURE AND THERE WERE NO ISSUES NOTED; HOWEVER, THE BALLOON WOULD NOT INFLATE WHEN INSIDE THE PATIENT. THE SECOND BALLOON WAS THEN REMOVED FROM THE PATIENT, AND LIQUID WAS NOTED COMING OUT OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD MAXFORCE BILIARY 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, GOOD AND FINE. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE;

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9990868 ↗
• MalfunctionApr 22, 2020Material Puncture/Hole; Obstruction of Flow; Material Puncture/Hole; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED DURING A DILATATION IN THE COMMON BILE DUCT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT IT WAS NOT POSSIBLE TO BUILD PRESSURE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY 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 9987004 ↗
• MalfunctionApr 22, 2020Material Puncture/Hole; Obstruction of Flow; Material Puncture/Hole; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A DILATATION PROCEDURE PERFORMED ON(B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE WATER AND CONTRAST MEDIUM WAS EMERGING FROM THE BALLOON. REPORTEDLY, THE BALLOON WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY 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 (SEE BLOCK H10 FOR INVESTIGATION DETAILS).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986335 ↗
• MalfunctionApr 21, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS FINE. 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 9981988 ↗
• MalfunctionMar 30, 2020Burst Container or Vessel; Burst Container or Vessel

  THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOONS WERE USED IN THE LOWER COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN INFLATED TO APPROXIMATELY 8 AM. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BILIARY BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897002 ↗
• MalfunctionMar 30, 2020Burst Container or Vessel; Burst Container or Vessel

  THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOONS WERE USED IN THE LOWER COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN INFLATED TO APPROXIMATELY AT 8 A.M. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BILIARY BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897000 ↗
• MalfunctionMar 17, 2020Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILE DUCT 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 DID NOT INFLATE. REPORTEDLY, THE BALLOON WAS THEN REMOVED FROM THE PATIENT AND WAS CHECKED. A HOLE WAS NOTICED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY 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 9841527 ↗
• MalfunctionMar 16, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT DID NOT INFLATE. REPORTEDLY, THE BALLOON WAS THEN REMOVED FROM THE PATIENT AND WAS CHECKED. A HOLE WAS NOTICED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY 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 9837115 ↗
• MalfunctionMar 16, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT DID NOT INFLATE. REPORTEDLY, THE BALLOON WAS THEN REMOVED FROM THE PATIENT AND WAS CHECKED. A HOLE WAS NOTICED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY 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 9837069 ↗
• MalfunctionMar 4, 2020Material Puncture/Hole; Material Puncture/Hole

  BOSTON SCIENTIFIC CORPORATION RECEIVED AN UNAUTHORIZED RETURN OF A MAXFORCE BILIARY DILATATION BALLOON. IT WAS FOUND THAT THE BALLOON HAD A PINHOLE, AND THE INFLATION LUMEN WAS BLOCKED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9785398 ↗