Imager II M0064003000Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729751922), received between Feb 8, 2023 and Apr 13, 2023 — classified as 2 deaths, 34 injuries.

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 18, 2026.

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.

• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGE II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED PAIN AND WAS READMITTED. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 16732459 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED SEPSIS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WHEREIN SHE WAS TREATED WITH ANTIBIOTICS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Sepsis

  MAUDE report 16732228 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED WOUND INFECTION AND WAS TREATED WITH WOUND PACKING AND ANTIBIOTICS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16731557 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, 8/10 DILATOR SHEATH SET AND PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED URINOMA AND HAD A CYSTO STENT PLACED TO HELP DRAIN THE URINOMA. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II, 8/10 DILATOR SHEATH SET AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 16731414 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED SEPTIC SHOCK AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Septic Shock

  MAUDE report 16714589 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II AND PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED SEPSIS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE IMAGER II AND PERCUTANEOUS ACCESS NEEDLE BUT THE RELATIONSHIP TO THE PROCEDURE WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED ON APRIL 3, 2023: IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS FOR SEPSIS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE IMAGER II AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Sepsis

  MAUDE report 16712495 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6) 2016. THE PATIENT EXPERIENCED GROSS HEMATURIA AND WAS ADMITTED FOR OBSERVATION. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON AND PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Hematuria

  MAUDE report 16712493 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, 8/10 DILATOR SHEATH SET AND PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6)2016. THE PATIENT EXPERIENCED ABDOMINAL PAIN AND WAS GIVEN INTRAVENOUS (IV) PAIN CONTROL. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS POSSIBLY RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Abdominal Pain

  MAUDE report 16710026 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN (B)(6)2019. THE PATIENT EXPERIENCED DELIRIUM AND WAS READMITTED. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II AND 8/10 DILATOR SHEATH SET BUT WAS PROBABLY RELATED TO THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON APRIL 3, 2023: IT WAS CLARIFIED THAT A PERCUTANEOUS ACCESS NEEDLE WAS NOT USED IN THE PROCEDURE.

  Patient problems: Confusion/ Disorientation

  MAUDE report 16709990 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, 8/10 DILATOR SHEATH SET AND PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN MAY 2016. THE PATIENT EXPERIENCED SEPSIS AND WAS GIVEN ANTIBIOTICS. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS NOT RELATED TO THE IMAGER II, 8/10 DILATOR SHEATH SET AND PERCUTANEOUS ACCESS NEEDLE, BUT WAS CAUSALLY RELATED TO THE PROCEDURE. IN THE PHYSICIAN'S ASSESSMENT THE EVENT WAS PROBABLY RELATED TO THE NEPHROMAX ,BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Sepsis

  MAUDE report 16706674 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN FEBRUARY 2021. THE PATIENT EXPERIENCED SEPSIS AND RESPIRATORY PROBLEM, REQUIRING INTENSIVE CARE UNIT (ICU), MECHANICAL VENTILATION AND IV ANTIBIOTICS.

  Patient problems: Respiratory Failure; Sepsis

  MAUDE report 16369561 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2023. THE PATIENT EXPERIENCED PNEUMOTHORAX AND REQUIRED CHEST TUBE PLACEMENT.

  Patient problems: Pneumothorax

  MAUDE report 16368414 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON AND PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2021. THE PATIENT EXPERIENCED PSEUDOANUERYSM AND SEPSIS, REQUIRING READMISSION, INTERVENTIONAL RADIOLOGY (IR) EMBOLIZATION AND IV ANTIBIOTICS.

  Patient problems: Pseudoaneurysm; Sepsis

  MAUDE report 16362720 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2020. THE PATIENT EXPERIENCED HEMORRHAGE, SEPSIS AND INFECTED PERINEPHRIC HEMATOMA, REQUIRING TRANSFUSION, ANTIBIOTICS, INTERVENTIONAL RADIOLOGY (IR) PERCUTANEOUS DRAIN PLACEMENT AND INTERVENTIONAL RADIOLOGY (IR) PERCUTANEOUS NEPHROSTOMY TUBE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Sepsis; Urinary Tract Infection

  MAUDE report 16362712 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A RIGHT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2019. THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY (AKI) AND OBSTRUCTION. THE PATIENT HAD TO BE READMITTED AND WAS GIVEN ANTIBIOTICS.

  Patient problems: Obstruction/Occlusion; Renal Failure

  MAUDE report 16362583 ↗
• DeathFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2022. DURING THE CYSTOSCOPY STENT PLACEMENT, THE PATIENT HAD A CARDIAC ARREST DUE TO PULMONARY EMBOLISM AND DIED. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT'S DEATH WAS DUE TO PULMONARY EMBOLISM AND NOT RELATED TO THE DEVICES USED.

  Patient problems: Cardiac Arrest; Pulmonary Embolism

  MAUDE report 16362363 ↗
• DeathFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2020. THE PATIENT HAD EXPLORATORY LAPAROSCOPIC NEPHRECTOMY, AND EXPERIENCED HEMORRHAGIC SHOCK, SEPSIS AND DIED. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS DUE TO SEPSIS AND NOT RELATED TO THE DEVICES USED. IN THE PHYSICIAN'S ASSESSMENT, THE DEVICES WERE RELATED TO THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock; Sepsis

  MAUDE report 16362216 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A RIGHT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2018. THE PATIENT EXPERIENCED HEMORRHAGE AND ACUTE KIDNEY INJURY (AKI), REQUIRING READMISSION, INTERVENTIONAL RADIOLOGY (IR) EMBOLIZATION AND TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Renal Failure

  MAUDE report 16361896 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON, IMAGER II AND 8/10 DILATOR SHEATH SET WERE USED DURING A LEFT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2017. THE PATIENT EXPERIENCED URETERAL OBSTRUCTION AND REQUIRED CYSTOSCOPY STENT WITH READMISSION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16353634 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2017. THE PATIENT EXPERIENCED ACUTE URINARY RETENTION AND A FOLEY CATHETER WAS PLACED.

  Patient problems: Urinary Retention

  MAUDE report 16352497 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2020. THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND REQUIRED ANTIBIOTICS. ADDITIONAL INFORMATION RECEIVED ON MARCH 20, 2023: IT WAS CLARIFIED BY THE PHYSICIAN THAT THE PATIENT DID NOT EXPERIENCE URINARY TRACT INFECTION (UTI).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Tract Infection

  MAUDE report 16352494 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMAGER II, NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE AND 8/10 DILATOR SHEATH SET WERE USED DURING A LEFT PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2020. THE PATIENT EXPERIENCED SEPTIC SHOCK DUE TO OBSTRUCTION AND REQUIRED ADMISSION TO INTENSIVE CARE UNIT (ICU), ANTIBIOTICS, VASOPRESSOR, AND A CYSTOSCOPY STENT.

  Patient problems: Obstruction/Occlusion; Septic Shock

  MAUDE report 16352425 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN NEPHROMAX BALLOON, PERCUTANEOUS ACCESS NEEDLE, IMAGER II AND 8/10 DILATOR SHEATH SET WERE USED DURING THE PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2021. THE PATIENT EXPERIENCED HEMOPNEUMOTHORAX. THE PATIENT HAD UNDERGONE OXYGEN AND OBSERVATION.

  Patient problems: Hemothorax; Pneumothorax

  MAUDE report 16345205 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THAT AN IMAGER II, NEPHROMAX BALLOON, INTRODUCER NEEDLES AND 8/10 DILATOR SHEATH WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN JULY 2018. THE PATIENT EXPERIENCED SEPTIC SHOCK. THE PATIENT HAD TO BE READMITTED AND WAS GIVEN ANTIBIOTICS.

  Patient problems: Septic Shock

  MAUDE report 16342923 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THAT AN IMAGER II, NEPHROMAX BALLOON, INTRODUCER NEEDLES AND 8/10 DILATOR SHEATH WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN JULY 2018. THE PATIENT EXPERIENCED SURGICAL SITE INFECTION AND REQUIRED IV ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16342678 ↗