Contour™ M0061802220Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729058502), received between May 16, 2017 and Aug 25, 2026 — classified as 7 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Detachment of Device or Device Component

  It was reported that a Contour Ureteral Stent was used during a Ureteroscopy. During the procedure, it was noticed that the tip of the stent broke off. The procedure was completed with another of the same stent. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50425863 ↗
• MalfunctionMay 20, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT, DURING THE REMOVAL OF KIDNEY STONES PROCEDURE, A CONTOUR URETERAL STENT WAS INTENDED TO BE USED. UPON UNPACKING, IT WAS FOUND THAT THE FRONT END OF THE STENT ADHERED AND THE MIDDLE PART WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226481 ↗
• MalfunctionApr 22, 2026Break; Material Deformation

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE FRONT END OF THE PRODUCT WAS ADHERED AND THE MIDDLE PART WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960862 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED INTO TWO PARTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877254 ↗
• MalfunctionDec 12, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A URETEROSCOPIC LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796856 ↗
• MalfunctionNov 18, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS TO BE USED IN A TRANSURETHRAL STENT PLACEMENT PROCEDURE. DURING UNPACKING, IT WAS OBSERVED THAT THE INNER PACKAGE WAS DAMAGED. THE STERILE BARRIER WAS REPORTED TO BE COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589497 ↗
• MalfunctionAug 25, 2025Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A CONTOUR URETERAL STENT WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE IN THE LEFT KIDNEY. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE STENT, IT WAS NOTICED THAT THE STENT WAS BUCKLING AND WOULD NOT ADVANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891793 ↗
• MalfunctionAug 22, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION, THE STENT FAILED TO ADVANCE TO THE KIDNEY ALONG WITH GUIDEWIRE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874907 ↗
• MalfunctionJul 10, 2025Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A CONTOUR STENT WAS USED IN A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, WHEN THE STENT WAS ADVANCED OVER THE GUIDEWIRE, IT WAS NOTICED THAT THE GUIDEWIRE WAS GETTING CAUGHT UP. THE GUIDEWIRE WAS CHANGED, BUT THE SAME THING HAPPENED. IT WAS ALSO OBSERVED THAT THE STENT WAS ACCORDIONED. THE STENT WAS SUCCESSFULLY IMPLANTED AND HAVE COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-44686 FOR THE FIRST CONTOUR STENT, AND 2124215-2025-44688 FOR THE SECOND CONTOUR STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472493 ↗
• MalfunctionJul 10, 2025Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT A CONTOUR STENT WAS USED IN A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, WHEN THE STENT WAS ADVANCED OVER THE GUIDEWIRE, IT WAS NOTICED THAT THE GUIDEWIRE WAS GETTING CAUGHT UP. THE GUIDEWIRE WAS CHANGED, BUT THE SAME THING HAPPENED. IT WAS ALSO OBSERVED THAT THE STENT WAS ACCORDIONED. THE STENT WAS SUCCESSFULLY IMPLANTED AND HAVE COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING. REFER TO MANUFACTURER REPORT NUMBER FOR THE FIRST CONTOUR STENT AND 2124215-2025-44688 FOR THE SECOND CONTOUR STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472198 ↗
• InjuryMay 15, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration; Material Deformation; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION AS A PREVENTIVE TREATMENT OF CLOSED PYELITIS, A CONTOUR URETERAL STENT WAS IMPLANTED IN THE LEFT KIDNEY TO ENSURE FREE OUTFLOW ON (B)(6) 2025. APPROXIMATELY 12 HOURS POST-PROCEDURE, THE PATIENT WOKE UP TO EXTREME PAIN IN THE FLANK, URETER, AND BLADDER. PAIN WAS EXPERIENCED DESPITE THE PRESCRIBED MEDICATION OF ADVIL OF 1G EVERY 4 HRS. AND OXYCODONE 10MG AS NEEDED. THE PATIENT'S TEMPERATURE REACHED 38.8, AND SUPERFICIAL BREATHING DUE TO PAIN FROM ABDOMINAL MOVEMENTS WAS EXPERIENCED. ON (B)(6) 2025, THE PATIENT WAS SENT TO THE EMERGENCY ROOM, AND CT-SCAN WAS TAKEN, WHICH SHOWED THAT THE STENT WAS DISLOCATED. THE STENT MIGRATED DOWN TO THE URETER AND THE OTHER HALF WAS IN THE BLADDER. A PROCEDURE WAS PERFORMED THE SAME DAY TO REPOSITION THE STENT. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Fever; Pain

  MAUDE report 22032201 ↗
• MalfunctionMay 7, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON TRIED TO INSERT THE STENT AND IT CRUMPLED BEFORE BEING FULLY PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976080 ↗
• InjuryJan 12, 2024Difficult to Remove; Difficult to Remove

  BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE EVENT THROUGH THE ARTICLE 'CAN PREOPERATIVE URETERAL STENTS REDUCE THE INCIDENCE OF URETERAL STRICTURE AFTER RADIOTHERAPY IN PATIENTS WITH CERVICAL CANCER?', LIANG LIU, CHUNHONG YU, FUZHEN SUN, TAO YANG, DONG WEI, GANG WANG, SHOUBIN LI, AND JUNJIANG LIU. PER THE ARTICLE, THE STUDY WAS A RETROSPECTIVE ANALYSIS OF DATA COLLECTED FROM 55 CERVICAL CANCER PATIENTS TREATED WITH RADIOTHERAPY BETWEEN (B)(6) 2016 AND (B)(6) 2020. THE PATIENTS IN THE STUDY WERE DIVIDED INTO A CONTROL GROUP WHO DID NOT RECEIVE STENT PLACEMENT AND A GROUP WHO RECEIVED URETERAL STENT PLACEMENT BEFORE RADICAL HYSTERECTOMY AND THE STENTS WERE REMOVED AT 3 MONTHS AFTER RADIOTHERAPY. THE STRICTURE RATE AND THE COMPLICATIONS RELATED TO STENT PLACEMENT BETWEEN THE 2 GROUPS WERE COMPARED. THE INCIDENCE RATES OF URETER STRICTURE IN THE TWO GROUPS WERE NOT SIGNIFICANTLY DIFFERENT. COMPLICATIONS RELATED TO STENT PLACEMENT SUCH AS URINARY TRACT INFECTIONS AND BLADDER IRRITATION WERE STATISTICALLY SIGNIFICANT BETWEEN THE TWO GROUPS. THE PATIENTS IN THE STENT GROUP WERE TREATED IN THE LITHOTOMY POSITION, AND THE CYSTOSCOPE WAS PLACED UNDER ANESTHESIA. ZEBRA GUIDEWIRES WERE U

  Patient problems: Fever; Hematuria; Pain; Skin Inflammation/ Irritation; Urethral Stenosis/Stricture; Urinary Tract Infection

  MAUDE report 18509178 ↗
• MalfunctionDec 8, 2023Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS OPENED TO BE USED FOR A STENT REPLACEMENT PROCEDURE PERFORMED ON NOVEMBER 13, 2023. DURING THE PROCEDURE, WHEN THE DEVICE WAS UNPACKED, THE STENT WAS FOUND DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CONTOUR URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297103 ↗
• InjuryJan 20, 2023Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THEY HAD DIFFICULTY PULLING THE GUIDEWIRE FROM THE PATIENT AND FOUND THAT THE STENT WAS CATCHING ON SOMETHING INSIDE THE URETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CONTOUR URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215800 ↗
• InjuryAug 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE FOR STONE MANAGEMENT FOR STONES IN THE LEFT URETER PERFORMED ON (B)(6) 2022 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE CONTOUR URETERAL STENT WAS PLACED FOR STONE MANAGEMENT FOR STONE; LASER LITHOTRIPSY (WITH OR WITHOUT EXTRACTION) UNDER FLUOROSCOPY AND CYSTOSCOPY IN THE LEFT URETER. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. THE PROCEDURE WAS PERFORMED WITHOUT ANY COMPLICATIONS. DISCHARGE MEDICATION INCLUDED NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). THERE IS NO INFORMATION IF A NEW STENT WAS IMPLANTED. DURING POST PROCEDURE, THE PATIENT EXPERIENCED SEVERE LEFT LUMBAR PAIN DURING URINATION AND MILD HEMATURIA WITHOUT CLOT. THE PATIENT WAS GIVEN TRAMADOL AS MEDICATION FOR PAIN AND HEMATURIA. THE RELATIONSHIP OF THE ADVERSE EVENT TO THE DEVICE AND THE PROCEDURE WAS REPORTEDLY TO BE PROBABLY RELATED. ON (B)(6) 2022, A PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED, THE STENT WAS SUCCESSFULLY REMOVED WITHOUT ANY DIFFICULTY. PAIN CONTROL OF LOCAL ANESTHESIA WAS REQUIRED. THERE WERE NO NEW DEVICE IMPLANTED. NO ISSUES WER

  Patient problems: Hematuria; Pain

  MAUDE report 15263327 ↗
• InjuryJun 2, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE STENT, IT WAS NOTICED THAT THE STENT BROKE INTO PIECES. IT IS UNKNOWN ON HOW THE BROKEN PIECE WERE REMOVED BUT IT WAS REPORTED THAT ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. ANOTHER CONTOUR URETERAL WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922667 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING UNPACKING, THE PART OF THE STENT WAS BROKEN OFF. ANOTHER CONTOUR URETERAL STENT WAS OPENED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 GOOD. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608657 ↗
• MalfunctionNov 18, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER. THE PROCEDURE DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AND INSIDE THE PATIENT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE AMPLATZ SUPER STIFF GUIDEWIRE OUT OF THE CONTOUR URETERAL STENT, IT WAS NOTICED THAT THE STENT WAS ACCORDIONED/FRAYED AT THE DISTAL END. THE CONTOUR URETERAL STENT WAS REMOVED. ANOTHER CONTOUR URETERAL STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE ORIGINAL AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10859961 ↗
• MalfunctionNov 18, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER. THE PROCEDURE DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AND INSIDE THE PATIENT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE AMPLATZ SUPER STIFF GUIDEWIRE OUT OF THE CONTOUR URETERAL STENT, IT WAS NOTICED THAT THE STENT WAS ACCORDIONED/FRAYED AT THE DISTAL END. THE CONTOUR URETERAL STENT WAS REMOVED. ANOTHER CONTOUR URETERAL STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE ORIGINAL AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10859960 ↗
• MalfunctionNov 18, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER. THE PROCEDURE DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE AMPLATZ SUPER STIFF GUIDEWIRE OUT OF THE CONTOUR URETERAL STENT, IT WAS NOTICED THAT THE STENT WAS ACCORDIONED/FRAYED AT THE DISTAL END. THE CONTOUR URETERAL STENT WAS REMOVED. ANOTHER CONTOUR URETERAL STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE ORIGINAL AMPLATZ SUPER STIFF GUIDEWIRE. THERE ANOTHER CONTOUR URETERAL STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10858584 ↗
• MalfunctionNov 18, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER. THE PROCEDURE DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE AMPLATZ SUPER STIFF GUIDEWIRE OUT OF THE CONTOUR URETERAL STENT, IT WAS NOTICED THAT THE STENT WAS ACCORDION/FRAYED AT THE DISTAL END. THE CONTOUR URETERAL STENT WAS REMOVED. ANOTHER CONTOUR URETERAL STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE ORIGINAL AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10858581 ↗
• MalfunctionOct 12, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS OPENED TO BE USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER, KIDNEY AND BLADDER, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, WHILE UNPACKING THE DEVICE, IT WAS NOTICED THAT THE STENT SHAFT WAS BROKEN IN HALF INSIDE THE PACKAGING. ANOTHER CONTOUR URETERAL STENT WAS OPENED, AND SUCCESSFULLY COMPLETED THE PROCEDURE. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10667078 ↗
• InjuryNov 12, 2018Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR URETERAL STENT WAS IMPLANTED DURING A LEFT URETEROSCOPY, LASER LITHOTRIPSY, BASKET STONE EXTRACTION, RETROGRADE PYELOGRAM, AND URETERAL STENT INSERTION PROCEDURE PERFORMED IN THE LEFT URETER FOR TREATMENT OF LEFT URETERAL CALCULUS ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, POST PROCEDURE THE VERY SAME EVENING, THE STENT WAS REPORTED TO HAVE FELL OUT OF POSITION. THE PATIENT WAS REPORTED TO HAVE HAD SEVERE FLANK PAIN AND NAUSEA AND WAS ADMITTED TO THE HOSPITAL OVERNIGHT. THE PATIENT WAS REPORTED TO HAVE BEEN GOOD ON POD1 AND OFFICE CYSTOSCOPY TO REMOVE THE STENT FROM HER BLADDER WAS PERFORMED IMMEDIATELY FOLLOWING DISCHARGE. THERE WAS NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: Nausea; Pain

  MAUDE report 8062329 ↗
• InjuryAug 16, 2017Break; Calcified; Difficult to Remove; Break; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR STENT WAS IMPLANTED IN A PATIENT ON (B)(6) 2017, AND WAS ATTEMPTED TO BE REMOVED DURING AN ESWL PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A 22 FRENCH RIGID CYSTOSCOPE WAS PASSED INTO THE URETHRA AND BLADDER UNDER DIRECT VISION AND APPEARED TO BE NORMAL. WHEN ENTERING THE BLADDER, IT WAS NOTICED THAT THERE WAS A LARGE BLADDER STONE, ACUTE AND CHRONIC INFLAMMATION, AND IRRITATION OF THE BLADDER. HOWEVER, NO LESION ASSOCIATED WITH THE BLADDER WAS OBSERVED. A 900 LASER FIBER AT ABOUT 14 WATTS POWER WAS USED TO BREAK THE STONE INTO MULTIPLE FRAGMENTS, UNTIL THE STENT WAS COMPLETELY EXPOSED. AN ELLIK EVACUATOR WAS USED TO IRRIGATE THE FRAGMENTS OUT OF THE BLADDER, AND THE PROCESS WAS REPEATED FOR 90 PERCENT OF THE FRAGMENTS. THE STENT WAS THEN GRASPED AND THE STENT BROKE OFF JUST BEYOND THE UTEROVESICAL JUNCTION. THE STENT WAS THOUGHT TO HAVE BEEN WEAKENED FROM THE LASER FIBER, AND WAS STILL EMBEDDED WITHIN THE KIDNEY STONE. THE PATIENT WAS DISCHARGED HOME AND SCHEDULED FOR PERCUTANEOUS NEPHROLITHOTOMY FOR (B)(6) 2017 TO REMOVE HIS KIDNEY STONE AND THE REMAINING STENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6798349 ↗