Alliance II M00550600Recalls & reported problems

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 08714729746737), received between Feb 10, 2017 and Jul 31, 2026 — classified as 2 injuries, 189 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (160 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 191 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50107500 ↗
• MalfunctionJul 21, 2026Unsealed Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25893187 ↗
• MalfunctionJun 4, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II SYRINGE WAS ATTEMPTED TO BE USED IN THE MAIN PAPILLA DURING AN ENDOSCOPIC LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PRESSURE GAUGE ON THE DEVICE DID NOT INCREASE, MAKING IT UNCLEAR HOW MANY ATMOSPHERES OF INFLATION HAD BEEN ACHIEVED. AS A RESULT, THE BALLOON WAS DEFLATED. THE PROCEDURE WAS COMPLETED USING ANOTHER ALLIANCE SYRINGE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399454 ↗
• MalfunctionJun 2, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II SYRINGE INFLATION DEVICE WAS ATTEMPTED TO BE USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE FOR A DISTAL ESOPHAGEAL STRICTURE DUE TO EOE (EOSINOPHILIC ESOPHAGITIS). PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE GAUGE WAS NOT MOVING UP AT A CONSISTENT RATE AND WAS NOT ACCURATELY INCREASING IN PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368506 ↗
• MalfunctionMar 16, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS USED DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PRESSURE GAUGE ON THE SYRINGE WAS DEFECTIVE. THE FIRST TIME IT WAS PRESSURIZED, IT DID NOT INDICATE A PROPER PRESSURE. 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 24612029 ↗
• MalfunctionMar 6, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS BEING PREPARED FOR USE IN THE ESOPHAGUS DURING A DILATION PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE GAUGE DOES NOT SHOW THE PRESSURE OF THE BALLOON DURING INFLATION. THE SAME PROBLEM OCCURRED WITH THE SECOND BALLOON WITH DIFFERENT LOT NUMBER. THE PROCEDURE WAS NOT COMPLETED AND WAS CANCELED; HOWEVER, THE PATIENT WAS NOT SEDATED WHEN THE PROCEDURE WAS CANCELED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531270 ↗
• MalfunctionMar 6, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS BEING PREPARED FOR USE IN THE ESOPHAGUS DURING A DILATION PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE GAUGE DOES NOT SHOW THE PRESSURE OF THE BALLOON DURING INFLATION. THE SAME PROBLEM OCCURRED WITH THE SECOND BALLOON WITH DIFFERENT LOT NUMBER. THE PROCEDURE WAS NOT COMPLETED AND WAS CANCELED; HOWEVER, THE PATIENT WAS NOT SEDATED WHEN THE PROCEDURE WAS CANCELED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531255 ↗
• MalfunctionDec 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING A DILATION OF CBD PROCEDURE TO TREAT STRICTURES IN COMMON BILE DUCT PERFORMED ON (B)(6) , 2025. DURING THE PROCEDURE, THE INFLATION DEVICE HAD NO PRESSURE AND THE GAUGE VALUES STATED BETWEEN 0 AND 1 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION SYRINGE. 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 HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923577 ↗
• MalfunctionDec 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE SYRINGE INFLATION DEVICE WAS USED DURING AN ENDOSCOPICALLY PERFORMED BILIARY DRAINAGE (EPBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, PRESSURE GAUGE DID NOT MOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE SYRINGE. 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 23871399 ↗
• MalfunctionNov 26, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE TO TREAT ESOPHAGEAL STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE OF THE MANOMETER SYRINGE RISES WHEN THE BALLOON IS INFLATED BUT RETURNS TO 0 EVEN WHEN THE SYSTEM IS LOCKED. THE DILATION WAS STOPPED BECAUSE THE DEVICE WAS NOT WORKING AND IT WAS IMPOSSIBLE TO SEE THE PRESSURE ON THE MANOMETER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, AND THE PATIENT WAS RESCHEDULED FOR ANOTHER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660403 ↗
• MalfunctionNov 3, 2025Display or Visual Feedback Problem; Leak/Splash; Display or Visual Feedback Problem; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS USED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. IT WAS REPORTED THAT AIR LEAK AT THE MANOMETER LEVEL WAS NOTICED, WHICH LEADS TO INCAPACITY TO DETERMINE THE CORRECT PRESSURE VALUE AND CORRECT INFLATION OF THE DILATION BALLOON. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457600 ↗
• MalfunctionOct 27, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ENDOSCOPIC ESOPHAGEAL DILATATION PROCEDURE TO TREAT ESOPHAGEAL STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS USED DURING AN ESOPHAGEAL STENOSIS DILATION. THE BALLOON WAS INJECTED WITH THE INFLATION MEDIUM AND NO PROBLEM WITH THE ENDOSCOPIC IMAGES OR BALLOON INFLATION. IT WAS REPORTED THAT THE PRESSURE GAUGE ON THE DEVICE REMAINED AT LESS THAN 1 ATM (AROUND 0.5 ATM) AND DID NOT RISE ANY FURTHER. THE BALLOON INFLATION WAS CONTINUED WHILE MONITORING THE INFLATION STATUS BY ENDOSCOPIC IMAGES. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL ALLIANCE II INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393948 ↗
• MalfunctionOct 21, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS UNPACKED ON (B)(6) 2025. IT WAS REPORTED THAT THE SEALING STICKER HAS BEEN PEELED OFF. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE STERILE BARRIER WAS COMPROMISED. THE DEVICE WAS NEVER IN SERVICE AND THERE WERE NO PATIENTS INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350282 ↗
• MalfunctionSep 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED DURING AN ESOPHAGEAL STRICTURE DILATION IN THE ESOPHAGUS PROCEDURE TO TREAT POSTOPERATIVE ESOPHAGEAL STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PRODUCT WAS USED AS USUAL; HOWEVER, THE GAUGE DID NOT RISE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION SYRINGE. 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 23000775 ↗
• MalfunctionAug 13, 2025Display or Visual Feedback Problem; Leak/Splash; Display or Visual Feedback Problem; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN UPPER ENDOSCOPY DILATION PROCEDURE TO TREAT A STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE LEAD TECHNICIAN STARTED TO DILATE TO THE FIRST SIZE. THE GAUGE DID NOT MOVE, AND THE SYRINGE LEAKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800921 ↗
• MalfunctionApr 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS BEING PREPARED FOR USE DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE SYRINGE DID NOT GENERATE THE NECESSARY PRESSURE FOR USE. THE PRESSURE GAUGE NEEDLE WOULD RISE BUT IT AUTOMATICALLY DECREASED. THE DEVICE WAS NEVER USED ON THE PATIENT. THE PROCEDURE WAS CANCELED AFTER PATIENT SEDATION AND IS CURRENTLY PENDING RESCHEDULING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938334 ↗
• MalfunctionApr 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ALLIANCE II INFLATION SYRINGES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN INFLATING THE BALLOON, THE GAUGE DID NOT REGISTER A PRESSURE READING (ATM). FLUID WAS DRAWN INTO THE BALLOON AND WAS CONFIRMED ON THE FLUOROSCOPIC SCREEN; HOWEVER, NO PRESSURE READING WAS DISPLAYED ON THE GAUGE. A SECOND SYRINGE DEVICE WAS ATTEMPTED TO BE USED BUT IT ALSO DID NOT HAVE A PRESSURE READING ON THE GAUGE. THE PROCEDURE WAS COMPLETED WITH A THIRD ALLIANCE II INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923119 ↗
• MalfunctionApr 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ALLIANCE II INFLATION SYRINGES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN INFLATING THE BALLOON, THE GAUGE DID NOT REGISTER A PRESSURE READING (ATM). FLUID WAS DRAWN INTO THE BALLOON AND WAS CONFIRMED ON THE FLUOROSCOPIC SCREEN; HOWEVER, NO PRESSURE READING WAS DISPLAYED ON THE GAUGE. A SECOND SYRINGE DEVICE WAS ATTEMPTED TO BE USED BUT IT ALSO DID NOT HAVE A PRESSURE READING ON THE GAUGE. THE PROCEDURE WAS COMPLETED WITH A THIRD ALLIANCE II INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923013 ↗
• MalfunctionApr 2, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS BEING PREPARED FOR USE ON A PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE TAPE (SEAL) WAS TORN. THE PRODUCT WAS NOT USED IN ANY PROCEDURE. 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 21758572 ↗
• MalfunctionApr 2, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PRODUCT WAS UNPACKED, THE METER HAD ALREADY EXCEEDED THE MAXIMUM VALUE FROM THE START. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755947 ↗
• MalfunctionDec 31, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT IS ONE OF THREE DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SYRINGES WOULD ALLOW THE BALLOON TO INFLATE, BUT THE GAUGE WOULD NOT MOVE ON THE SYRINGE, SO THEY COULD NOT SEE HOW MUCH THEY INFLATED THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048722 ↗
• MalfunctionDec 31, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT IS ONE OF THREE DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SYRINGES WOULD ALLOW THE BALLOON TO INFLATE, BUT THE GAUGE WOULD NOT MOVE ON THE SYRINGE, SO THEY COULD NOT SEE HOW MUCH THEY INFLATED THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048716 ↗
• MalfunctionDec 31, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT IS ONE OF THREE DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SYRINGES WOULD ALLOW THE BALLOON TO INFLATE, BUT THE GAUGE WOULD NOT MOVE ON THE SYRINGE, SO THEY COULD NOT SEE HOW MUCH THEY INFLATED THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION SYRINGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048714 ↗
• MalfunctionDec 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS USED DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DIAL WAS FAULTY AND NOT REGISTERING CORRECTLY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 05, 2024: IT WAS REPORTED THAT THE TYPE OF PROCEDURE PERFORMED WAS ESOPHAGEAL DILATATION AND THE ANATOMY LOCATION OF THE PROCEDURE WAS ESOPHAGUS. IT WAS REPORTED THAT INFLATION WAS SUCCESSFUL, HOWEVER, THE GAUGE READING WAS INACCURATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION SYRINGE WITH DIFFERENT LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887597 ↗
• MalfunctionNov 18, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE ALLIANCE II SYRINGE WAS CONNECTED TO THE DEVICE AND DILATION WAS PERFORMED BUT, THE PRESSURE MEASUREMENT ON THE GAUGE WAS NOT CORRECT. FLUOROSCOPY INDICATED THAT THE PRESSURE HAD INCREASED, AND THE BALLOON WAS INFLATED. THE SYRINGE WAS REMOVED, AND A SECOND ALLIANCE II INFLATION SYRINGE WAS ATTEMPTED TO BE USED BUT, AGAIN THE PRESSURE MEASUREMENT ON THE GAUGE WAS NOT CORRECT. THE PROCEDURE WAS COMPLETED WITH THE SECOND ALLIANCE II INFLATION SYRINGE ONLY BY CONFIRMATION UNDER FLUOROSCOPY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20717231 ↗