8/10 Dilator/Sheath Set M0062601200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729005551), received between Apr 7, 2022 and Aug 22, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE UROLOGIA JOURNAL THAT A STUDY WAS CONDUCTED TO DESCRIBE THE TECHNIC TO PERFORM TUBELESS PERCUTANEOUS NEPHROLITHOTOMY (TPCNL) TO EVALUATE THE PROCEDURE EFFICACY AND SAFETY. TPCNL PROCEDURE UTILIZED HEMOSTATIC MATRIX THAT IS FLOSEAL FOR THE CLOSURE OF THE PERCUTANEOUS TRACT, DEVELOPED THROUGH EXPERIENCED AT THE ENDOUROLOGY SPECIALIZED CENTER, OSPEDALE DI CAMPOSAMPIERO. DATA FROM PATIENTS CONSECUTIVELY TREATED FROM FEBRUARY 2017 TO DECEMBER 2019 FOR KIDNEY STONE >2 CM VIA PCNL, WHO UNDERWENT FLOSEAL DIRECT APPLICATION FOR PERCUTANEOUS TRACT CLOSURE, WERE INCLUDED. CLINICAL AND SURGICAL DATA WERE COLLECTED IN ORDER TO EVALUATE THE SUCCESS OF THE PROCEDURE AND POSSIBLE COMPLICATIONS. PREOPERATIVE ASSESSMENT DECLARED THAT PROCEDURES WERE PERFORMED UNDER SPINAL ANESTHESIA IN 69 PATIENTS (45 MALES MEAN AGE 58 YEARS OLD). FOR THE PROCEDURE TECHNIQUE, THE BOSTON SCIENTIFIC SENSOR PTFE-NITINOL GUIDEWIRE WITH HYDROPHILIC TIP, AMPLATZ SUPER STIFF GUIDEWIRE, NEPHROMAX BALLOON DILATOR, AND AMPLATZ RENAL SHEATH WERE UTILIZED. FOR THE LITHOTRIPSY PROCEDURES OF THE TONE, THE BOSTON SCIENTIFIC LUMENIS 20W HOLMIUM LASER, AND A ZERO T

  Patient problems: Fever; Hemorrhage/Blood Loss/Bleeding; Sepsis; Urinary Incontinence

  MAUDE report 20034268 ↗
• MalfunctionMar 13, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROSTOMY SHEATH AND DILATORS WAS USED IN THE URETER DURING A TRANSURETHRAL STONE CRUSHING PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AN INSECT CORPSE WAS FOUND INSIDE THE DEVICE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEPHROSTOMY SHEATH AND DILATOR. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529510 ↗
• InjuryDec 27, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NEPHROSTOMY DILATOR SHEATH DEVICE WAS USED IN THE KIDNEY/URETER DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, AN 8/10 DILATOR WAS PUSHED DOWN INTO THE URETER AND THAT PORTION WAS REMOVED; HOWEVER, A WHITE PIECE ON THE END OF OUTER PIECE CAME OFF IN THE PATIENT. IT WAS NOTED THAT EITHER THE PIECE THAT WAS TAKEN OFF FELL ON THE FLOOR OR POSSIBLY STILL IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ADDING ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2022. IT WAS NOTED THAT THE PHYSICIAN WAS USING C-ARM AND LOOKING VERY CLOSELY AT IMAGES AND THE LEFT SIDE DID NOT SEEM TO BE ACCEPTING THE CONTRAST DYE. AFTER FURTHER INVESTIGATION WITH SEMI RIGID URETEROSCOPY IT WAS FOUND THAT THERE WAS A BLUE LIKE OBJECT IN THE PROXIMAL TO DISTAL THIRD OF THE URETER. IT WAS REPORTED THAT AN ALLIGATOR FORCEPS WAS USED TO REMOVE THE OBJECT AND A LEFT STENT WAS PLACED. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT HAD A PERC NEPH ON THE DAY BEFORE THE PROCEDURE. GIVEN THE LENGTH OF THE CASE THEY

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16054027 ↗
• MalfunctionApr 7, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DILATOR SHEATH SET WAS ABOUT TO BE USED PRIOR TO PROCEDURE ON (B)(6) 2022. PRIOR TO PROCEDURE, THE PRODUCT WAS NEVER USED OR OPENED; HOWEVER, A BLACK HAIR WAS NOTICED INSIDE THE STERILE PACKAGING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046141 ↗