Percuflex™ Plus M0061752540Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08714729067757), received between Dec 5, 2016 and Jul 18, 2024 — classified as 30 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Calcified” (33 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Calcified; Calcified

  IT WAS REPORTED THAT, DURING A TRANSURETHRAL LITHOTOMY PROCEDURE, A PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, IT WAS FOUND THAT THE STENT WAS ENCRUSTED, AND IT WAS REMOVED FROM THE PATIENT. ANOTHER OF THE SAME STENT WAS USED TO REPLACE THE ENCRUSTED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779685 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164894 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164803 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LIHTOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164684 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LIHTOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164207 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LIHTOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164111 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163844 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LIHTOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162435 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHERAL LITHOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162406 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LITHOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162329 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LIHTOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162320 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LIHTOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162310 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LIHTOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162301 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHERAL LITHOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162298 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LIHTOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162251 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LITHOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162223 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETERAL LIHTOTOMY PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162211 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161569 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161444 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161421 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161282 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161204 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2022. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 23, 2023, STATING THE IMPLANT DATES FOR THE AFFECTED STENTS OCCURRED OVER SEVERAL MONTHS AND NOT ALL WERE PERFORMED BY THE SAME PHYSICIAN. IT WAS ALSO REPORTED THAT SOME OF THE STENTS WERE STILL ABLE TO DRAIN EVEN THOUGH THEY WERE FOUND ENCRUSTED. THE PATIENTS UNDERWENT REGULAR CHECKUPS AND AN UNSPECIFIED NUMBER OF PATIENTS HAD MEDICAL CONDITIONS OR MEDICATION THAT COULD HAVE CONTRIBUTED TO THE ENCRUSTATION. SOME OF THE PATIENTS UNDERWENT DIAGNOSTIC TESTING TO CONFIRM THEY HAD NO METABOLIC OR ELECTROLYTE PROBLEMS. THE STENTS WERE REMOVED EARLIER THAN THE SCHEDULED DATES WITH THE USE OF PNEUMATIC SYSTEM TO BREAK THE STONES AND ENCRUSTATION. SOME OF THE STENTS WERE REPORTED TO HAVE BEEN TORN, BUT WITH THE PNEUMATIC SYSTEM ALL PIECES OF THE STENTS WERE REMOVED. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161158 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161069 ↗
• InjuryJan 13, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A TRANSURETHRAL LITHOTOMY PROCEDURE IN THE URETER. THE PROCEDURE DATE IS UNKNOWN. POST PROCEDURE, IT WAS REPORTED THAT THERE WERE APPROXIMATELY 30 STENTS THAT WERE FOUND ENCRUSTED IN THE PATIENT'S BODY IN TWO WEEKS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161022 ↗