Hurricane™ RX M00545890Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729283805), received between Sep 6, 2018 and Mar 5, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (13 reports).

2 FDA recall records name this device's identifier, 2 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. Oct 21, 2021Open, Classified

   Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

   Z-0320-2022 · Root cause: Device Design · FDA record ↗

2. Sep 16, 2020Open, Classified

   RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

   Z-0286-2021 · Root cause: Vendor change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2025Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED THROUGH VIABIL, AND WAS ABLE TO BE INFLATED ONCE, WHILE FILLING IT THE SECOND TIME, THE BALLOON BURST AROUND 2-3ATM. THE SAME PROBLEM OCCURRED WITH THE SECOND HURRICANE RX DILATATION BALLOON. IT WAS REPORTED THERE WAS VIABIL STENT IN THE DUCT AND NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A THIRD HURRICANE RX 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529840 ↗
• MalfunctionJul 11, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS ATTEMPTED TO BE USED IN THE SPHINCTER OF ODDI DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON POPPED WHEN INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720204 ↗
• MalfunctionMay 20, 2024Break; Entrapment of Device; Detachment of Device or Device Component; Break; Entrapment of Device; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO A HURRICANE RX DILATATION BALLOON AND NAVIFLEX RX DELIVERY SYSTEM USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON AND NAVIFLEX RX DELIVERY SYSTEM WERE ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE RX TUNNEL (BLACK SEGMENT OR SHEATH) OF THE BALLOON DETACHED INSIDE THE SCOPE AND A PLASTIC STENT GOT STUCK INSIDE THE RX TUNNEL THAT DETACHED. A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE RX TUNNEL OF THE DEVICE WAS DETACHED. THE CUSTOMER REPORTED THAT THE CATHETER BROKE AND CONSEQUENTLY REPORTED THAT NO PIECES OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND WAS REPORTED TO BE RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355939 ↗
• MalfunctionAug 16, 2021Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE RX DILATATION BALLOON WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6),2021. DURING THE PROCEDURE, THE BALLOON BURST WHEN THE PHYSICIAN WAS DILATING A BILIARY STRICTURE WITH A 2X4 HURRICANE RX DILATATION BALLOON. REPORTEDLY, A 4X4 HURRICANE RX DILATATION BALLOON WAS THEN USED AND A PINHOLE LEAK WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2021*** THE ANATOMY LOCATION WAS THE COMMON BILE DUCT (CBD). ADDITIONALLY, THE FIRST BALLOON WAS NOTED TO BURST AT 11 ATM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324397 ↗
• MalfunctionJul 27, 2021Inflation Problem; Appropriate Device Problem Term/Code Not Available; Inflation Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) AND LEFT HEPATIC DUCT DURING A DILATION OF HEPATIC DUCT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, INFLATION OF THE BALLOON WAS ATTEMPTED; HOWEVER, THE BALLOON WOULD NOT INFLATE. REPORTEDLY, THE DEVICE WAS TAKEN OUT OF THE PATIENT AND WAS TESTED BUT INFLATION WAS STILL UNSUCCESSFUL. THE SAME PROBLEM OCCURRED WITH THE SECOND, THIRD AND FOURTH HURRICANE RX DILATATION BALLOONS. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS IT WAS CANCELLED BY THE PHYSICIAN AND THE PATIENT WAS REFERRED TO RADIOLOGY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228410 ↗
• MalfunctionJul 27, 2021Inflation Problem; Appropriate Device Problem Term/Code Not Available; Inflation Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) AND LEFT HEPATIC DUCT DURING A DILATION OF HEPATIC DUCT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, INFLATION OF THE BALLOON WAS ATTEMPTED; HOWEVER, THE BALLOON WOULD NOT INFLATE. REPORTEDLY, THE DEVICE WAS TAKEN OUT OF THE PATIENT AND WAS TESTED BUT INFLATION WAS STILL UNSUCCESSFUL. THE SAME PROBLEM OCCURRED WITH THE SECOND, THIRD AND FOURTH HURRICANE RX DILATATION BALLOONS. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS IT WAS CANCELLED BY THE PHYSICIAN AND THE PATIENT WAS REFERRED TO RADIOLOGY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228236 ↗
• MalfunctionMay 26, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885295 ↗
• MalfunctionApr 28, 2021Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, A SHARP STONE IN THE DISTAL PANCREATIC DUCT POPPED BOTH BALLOONS WHILE TRYING TO PULL OUT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740747 ↗
• MalfunctionMar 16, 2021Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON HAD A PINHOLE LEAK. REPORTEDLY, A SECOND HURRICANE RX DILATATION BALLOON WAS TAKEN OUT BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494663 ↗
• MalfunctionMar 16, 2021Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON HAD A PINHOLE LEAK. REPORTEDLY, A SECOND HURRICANE RX DILATATION BALLOON WAS TAKEN OUT BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A THIRD HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494241 ↗
• MalfunctionFeb 25, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR HURRICANE RX DILATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOONS WERE LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION 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 11380623 ↗
• MalfunctionNov 13, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE LEAKING WHILE BEING INFLATED AND WOULD NEVER STAY INFLATED. REPORTEDLY, THE BALLOON WAS TAKEN OUT OF THE PATIENT AND THE PROCEDURE WAS CONTINUED. 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 10837259 ↗
• MalfunctionMay 7, 2020Material Puncture/Hole; Obstruction of Flow; Material Puncture/Hole; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO HURRICANE RX DILATION BALLOONS WERE 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 TWO BALLOONS DID NOT INFLATE AT ALL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 10035141 ↗
• MalfunctionMay 7, 2020Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO HURRICANE RX DILATION BALLOONS WERE 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 TWO BALLOONS DID NOT INFLATE AT ALL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 10034405 ↗
• MalfunctionApr 29, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH DILATATION PROCEDURE PERFORMED IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE INFLATING, A LEAK WAS NOTICED ON THE PROXIMAL EDGE OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON FOUND A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009727 ↗
• MalfunctionApr 20, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH PANCREATIC STRICTURE DILATION PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 8 ATM; HOWEVER, WHEN DEFLATION WAS REQUESTED, THE DEVICE WAS PULLED BACK INSTEAD OF DEFLATING. REPORTEDLY, THE BALLOON BURST AND LEFT CONTRAST DYE IN THE PANCREATIC DUCT. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978108 ↗
• MalfunctionJan 21, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612140 ↗
• MalfunctionDec 11, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO HURRICANE RX DILATION BALLOONS WERE USED IN THE PANCREATICOBILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE TWO BALLOONS BOTH HAD A SMALL HOLE, CAUSING CONTRAST LEAKAGE IN THE BILE DUCT. THE PHYSICIAN DECIDED TO NOT DILATE FURTHER, AND THE PROCEDURE WAS COMPLETED WITH A PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS CONFIRMED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451894 ↗
• MalfunctionDec 11, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO HURRICANE RX DILATION BALLOONS WERE USED IN THE PANCREATICOBILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE TWO BALLOONS BOTH HAD A SMALL HOLE, CAUSING CONTRAST LEAKAGE IN THE BILE DUCT. THE PHYSICIAN DECIDED TO NOT DILATE FURTHER, AND THE PROCEDURE WAS COMPLETED WITH A PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS CONFIRMED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451866 ↗
• MalfunctionApr 26, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO HURRICANE RX DILATION BALLOONS WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED THAT THE TWO BALLOONS WERE PUNCTURED IN THE DISTAL RO MARKER THAT CREATED A SMALL HOLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556303 ↗
• MalfunctionApr 11, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS CAUGHT INSIDE THE D-SCOPE AND THEN POPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503674 ↗
• MalfunctionMar 12, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO HURRICANE RX DILATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE TWO BALLOONS LEAKED. THE PROCEDURE WAS COMPLETED WITH A PLASTIC STENT. 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 8414016 ↗
• MalfunctionMar 11, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS AND A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER AND TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WORKING CHANNEL SLEEVE PROTRUDED. REPORTEDLY, NO ACCESSORY DEVICE WAS INSIDE THE SPYSCOPE DS WHEN THE WORKING CHANNEL SLEEVE PROTRUDED. A HURRICANE RX DILATATION BALLOON WAS ALSO USED AND THE BALLOON PART BROKE OFF. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON AND A SECOND SPYSCOPE DIGITAL ACCESS AND DELIVERY CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. CORRECTION: A HURRICANE RX DILATATION BALLOON WAS ALSO USED AND THE BALLOON BURST. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407768 ↗
• MalfunctionJan 3, 2019Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST WHEN INFLATED TO 11 ATM. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8212850 ↗
• MalfunctionNov 28, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON HAD A HOLE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON FOUND A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8109979 ↗