NA M0067001210Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 08714729077749), received between Feb 8, 2023 and Apr 13, 2023 — classified as 2 deaths, 45 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 48 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 OCTOBER 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 16732713 ↗
• 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 16732238 ↗
• 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 16732187 ↗
• 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 16732018 ↗
• InjuryApr 12, 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 AND WAS GIVEN ANTIBIOTICS. 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 16728083 ↗
• 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, 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 BALLLOON, PERCUTANEOUS ACCESS NEEDLE BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Abdominal Pain

  MAUDE report 16712708 ↗
• 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 JUNE 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 16712664 ↗
• 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 BALLOON BUT WAS CAUSALLY RELATED TO THE PROCEDURE.

  Patient problems: Septic Shock

  MAUDE report 16712313 ↗
• 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 (B)(6) 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 16706901 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUTANEOUS ACCESS NEEDLE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2021. THE PATIENT EXPERIENCED SEPSIS /OBSTRUCTION AND REQUIRED READMISSION/IR PERC TUBE PLACEMENT.

  Patient problems: Obstruction/Occlusion; Sepsis

  MAUDE report 16375784 ↗
• 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 16369573 ↗
• 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 TWO DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROMAX BALLOON AND A PERCUTANEOUS ACCESS NEEDLE WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN FEBRUARY 2021. THE PATIENT EXPERIENCED SEPSIS AND DISLODGEMENT OF NEPHROSTOMY TUBE WITH OBSTRUCTION, REQUIRING READMISSION WITH LEFT INTERVENTIONAL RADIOLOGY (IR) PERCUTANEOUS NEPHROSTOMY TUBE AND ANTIBIOTICS.

  Patient problems: Obstruction/Occlusion; Sepsis

  MAUDE report 16369180 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR DEVICE WAS IMPLANTED DURING A SPACEOAR PLACEMENT ON AN UNKNOWN DATE. AFTER SPACEOAR PLACEMENT THE PATIENT EXPERIENCED PAIN, INFLAMMATION, EDEMA, A RECTO-URETHRA FISTULA, A GASTROINTESTINAL ULCER, INFECTION, AND SEPSIS. THE PATIENT'S PERINEUM PRESENTED WITH GANGRENE WHICH REQUIRED COLOSTOMY, SURGICAL DISSECTION OF THE PERINEUM, AND AMPUTATION OF THE TESTICLE. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE AND WAS REPORTED TO HAVE BEEN DISCHARGED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL DETAILS, DESPITE GOOD FAITH EFFORTS (GFES).

  Patient problems: Pleural Effusion

  MAUDE report 16368234 ↗
• 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 TWO DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THAT AN INTRODUCER NEEDLES AND 8/10 DILATOR SHEATH WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN OCTOBER 2018. THE PATIENT EXPERIENCED RESPIRATORY FAILURE AND REQUIRED ICU WITH BILEVEL POSITIVE AIRWAY PRESSURE.

  Patient problems: Respiratory Failure

  MAUDE report 16368181 ↗
• 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, INTRODUCER NEEDLES AND 8/10 DILATOR SHEATH WERE USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED IN DECEMBER 2018. THE PATIENT EXPERIENCED BLADDER CLOTS. THE PATIENT REQUIRED CYSTO CLOT EVACUATION UNDER ANESTHESIA AND URETERAL STENT EXCHANGE.

  Patient problems: Hematuria

  MAUDE report 16368128 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 PSEUDOANEURYSM AND SEPSIS, REQUIRING READMISSION, INTERVENTIONAL RADIOLOGY (IR) EMBOLIZATION AND IV ANTIBIOTICS.

  Patient problems: Pseudoaneurysm; Sepsis

  MAUDE report 16362723 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUTANEOUS ACCESS NEEDLE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2019. THE PATIENT EXPERIENCED PNEUMONIA. THE PATIENT WAS GIVEN ANTIBIOTICS FOR C. DIFFICILE AND PNEUMONIA. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: IT WAS REPORTED THAT IN ADDITION TO PNEUMONIA, THE PATIENT EXPERIENCED PSEUDOMEMBRANOUS COLITIS AND WAS GIVEN ANTIBIOTICS FOR C. DIFFICILE INFECTION.

  Patient problems: Inflammation; Pneumonia

  MAUDE report 16362719 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUTANEOUS ACCESS NEEDLE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED IN (B)(6) 2020. THE PATIENT EXPERIENCED PNEUMOTHORAX AND REQUIRED OXYGEN.

  Patient problems: Pneumothorax

  MAUDE report 16362718 ↗
• 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 16362650 ↗
• 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 16362328 ↗
• 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 16362209 ↗
• 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 16361963 ↗
• 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 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 16361585 ↗
• 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) 2021. THE PATIENT EXPERIENCED SEPTIC SHOCK AND RESPIRATORY DECOMPENSATION. IT WAS REPORTED THAT THE PATIENT WAS INTUBATED AND WAS SENT TO THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Respiratory Insufficiency; Septic Shock

  MAUDE report 16357918 ↗
• 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 16352426 ↗