Amplatz Super Stiff M0066401090Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729752714), received between Aug 15, 2017 and Dec 11, 2024 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE PLANNED STONE EXTRACTION AND URETERAL STENT EXCHANGE. WHILE GRASPING THE RIGHT STENT, THE SURGEON REMOVED A PIECE OF BROKEN AMPLATZ SUPER STIFF GUIDEWIRE IN THE URETER FROM THE PRIOR STENT PLACEMENT PROCEDURE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE AND PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20900001 ↗
• MalfunctionFeb 1, 2024

  AMPLATZ WIRE UNCOILED AT THE TIP WHILE INSIDE THE PATIENT. BOTH THE WIRE AND DILATOR EVENTUALLY WERE REMOVED FROM THE BODY INTACT. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621315 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A URETEROSCOPIC PROCEDURE IN THE LEFT KIDNEY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE GUIDEWIRE BROKE. THE PHYSICIAN SEARCHED FOR ALL PIECES BUT WAS UNSURE IF ANY WERE LEFT. THERE WAS NO FRAGMENT FOUND IN THE KIDNEY, URETER, AND BLADDER, BUT THERE WAS A MODERATE AMOUNT OF BLOOD AND SMALL CLOTS IN THE BLADDER. THE GUIDEWIRE WAS SO THIN IT MAY HAVE BEEN TRAPPED IN A CLOT AND NOT VISIBLE ON X-RAYS. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL AMPLATZ SUPER STIFF DEVICE. 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 17776418 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS PLACED INSIDE THE PATIENT, THE CORE WIRE BROKE. REPORTEDLY, THE KIDNEY AND URETER WERE EXAMINED, AND THERE WERE NO SIGNS OF ANY RETAINED WIRE FRAGMENTS. THE PROCEDURE WAS COMPLETED WITH SAME ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484353 ↗
• MalfunctionApr 24, 2023Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A PROCEDURE IN THE KIDNEY ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS BENT AND FRAYED AT THE TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE CORE WIRE BROKE. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794423 ↗
• MalfunctionApr 24, 2023Entrapment of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN ADVANCES A SENSOR WIRE, ALSO HAS THE AMPLATZ GUIDEWIRE ADVANCED IN URETER. THEN ADVANCES THE RIGID URETEROSCOPE OVER THE AMPLATZ WIRE. ONCE SCOPE IS ADVANCED AND IN PLACE, WHEN ATTEMPTING TO REMOVE/WITHDRAW THE AMPLATZ WIRE IT WAS STUCK. IT REQUIRED MORE PULL TO REMOVE THE WIRE, UPON DOING SO PIECES OF THE COATING SHREDDING FROM THE WIRE. THE PHYSICIAN FLUSHED OUT THE PIECES FROM THE PATIENT. RATHER THAN GRAB ANOTHER AMPLATZ, A SECOND SENSOR WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE CORE WIRE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794338 ↗
• MalfunctionApr 20, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A URETEROSCOPY PROCEDURE IN THE KIDNEY ON (B)(6) 2023. IT WAS REPORTED THAT NEARING THE END OF THE PROCEDURE, THE AMPLATZ WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH A SENSOR WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781646 ↗
• MalfunctionApr 19, 2023Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY ON (B)(6), 2023. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS STRETCHED OUT AND THE TIP WAS ANGLED. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE COIL WIRE WAS KINKED, AND THE CORE WIRE WAS DETACHED AT DISTAL TIP SECTION. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773155 ↗
• MalfunctionApr 14, 2023Peeled/Delaminated; Detachment of Device or Device Component; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Detachment of Device or Device Component; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE ON (B)(6) 2023. DURING PROCEDURE, THE GUIDEWIRE HAD DIFFICULTY ADVANCING WITH 8/10 DILATOR AND GOT DAMAGED LIKE SPLIT, FRAYED AND DISHEVELED. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE COIL WIRE WAS UNRAVELED, AND THE CORE WIRE WAS DETACHED AT DISTAL TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746119 ↗
• MalfunctionApr 12, 2023Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE TWO OF TWO AMPLATZ SUPER STIFF USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE COIL WIRE WAS UNRAVELED, AND THE CORE WIRE WAS DETACHED AT DISTAL TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727307 ↗
• MalfunctionApr 12, 2023Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO AMPLATZ SUPER STIFF USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF THE COIL WIRE WAS UNRAVELED, AND THE CORE WIRE WAS DETACHED AT DISTAL TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726071 ↗
• MalfunctionFeb 17, 2023Break; Entrapment of Device; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Break; Entrapment of Device; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN A CYSTO URETEROSCOPY LASER LITHOTRIPSY AND RIGHT URETERAL STENT PROCEDURE ON (B)(6) 2022. DURING PROCEDURE, WHEN CATHETER WAS REMOVED, THE GUIDEWIRE FRAYED, AND IT GOT STUCK INSIDE THE DUAL LUMEN CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16399553 ↗
• MalfunctionSep 29, 2022Break; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Break; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING PREPARATION, THE PTFE COATING PEELED. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE BREAK. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508900 ↗
• MalfunctionMay 4, 2022Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AMPLATZ SUPER STIFF AS BEING USED IN A PROCEDURE PERFORMED ON (B)(6) 2021. DURING INSERTION, THE PLASTIC COVERING ON THE WIRE CAME OFF IN USE, AND UNCOILED. THIS WAS NOTICED UPON REMOVAL. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283236 ↗
• MalfunctionJun 16, 2021Break; Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Break; Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  THIS REPORT PERTAINS TO A AMPLATZ SUPER STIFF AND PERCUFLEX PLUS URETERAL STENT WERE USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# (B)(4) AND 3005099803-2021-02164 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AMPLATZ SUPER STIFF AND PERCUFLEX PLUS URETERAL STENT WAS USED DURING A CYSTO, STENT PLACEMENT PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE WIRE SHREDDED AND WAS STUCK IN THE STENT. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009245 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED IN A PROCEDURE. PROCEDURE DATE IS UNKNOWN. DURING PREPARATION, THE GUIDEWIRE DISTAL TIP DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE AND COILWIRE WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11923521 ↗
• MalfunctionSep 16, 2019Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE UNRAVELED. THE PROCEDURE WAS COMPLETED USING A NON BSC GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9069869 ↗
• MalfunctionOct 30, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF¿ GUIDEWIRE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE WAS NOT USED AS IT WAS FOUND NOT STIFF AND THE STAINLESS STEEL WAS STICKING OUT. REPORTEDLY, THE GUIDEWIRE REMAINED INTACT AS ONE AND DID NOT SEPARATE. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF¿ GUIDEWIRE. 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 FINE. INVESTIGATION RESULTS REVEALED ON OCTOBER 12, 2017 THAT THE CORE WIRE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6986781 ↗
• MalfunctionAug 15, 2017Break; Break

  NOTE: THIS REPORT PERTAINS TO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2017-01805 FOR THE FLEXIVA 200 TRACTIP LASER FIBER, 3005099803-2017-02444 FOR THE FIRST AMPLATZ SUPER STIFF¿, 3005099803-2017-02445 FOR THE SECOND AMPLATZ SUPER STIFF¿, AND 3005099803-2017-02446 FOR THE THIRD AMPLATZ SUPER STIFF¿. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE FLEXIVA 200 TRACTIP LASER FIBER AND FOUR AMPLATZ SUPER STIFF¿ WERE USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LASER FIBER BURNED BACK QUICKLY IN 2 MINUTES OF USE WITH MINIMAL POWER OF THE LASER. TWO MORE FLEXIVA 200 TRACTIP LASER FIBER WERE USED AND THE TWO LASER FIBERS BURNED BACK QUICKLY AGAIN IN 2 MINUTES OF USE WITH MINIMAL POWER OF THE LASER. REPORTEDLY, THE LASER UNIT USED FOR THE THREE LASER FIBERS WAS A LUMENIS P120 WITH SETTINGS OF 0.3/80 JOULES. THE TOTAL ENERGY OF THE THREE LASER FIBERS WERE 4.56 KILOJOULES, 4.56 KILOJOULES, AND 5.0 KILOJOULES, RESPECTIVELY. IT WAS ALSO NOTICED DURING THE PROCEDURE THAT THE FOUR AMPLATZ SUPER STIFF¿ GUIDEWIRES U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6795089 ↗
• MalfunctionAug 15, 2017Break; Break

  NOTE: THIS REPORT PERTAINS TO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2017-01805 FOR THE FLEXIVA 200 TRACTIP LASER FIBER, 3005099803-2017-02444 FOR THE FIRST AMPLATZ SUPER STIFF¿, 3005099803-2017-02445 FOR THE SECOND AMPLATZ SUPER STIFF¿, AND 3005099803-2017-02446 FOR THE THIRD AMPLATZ SUPER STIFF¿. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE FLEXIVA 200 TRACTIP LASER FIBER AND FOUR AMPLATZ SUPER STIFF¿ WERE USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LASER FIBER BURNED BACK QUICKLY IN 2 MINUTES OF USE WITH MINIMAL POWER OF THE LASER. TWO MORE FLEXIVA 200 TRACTIP LASER FIBER WERE USED AND THE TWO LASER FIBERS BURNED BACK QUICKLY AGAIN IN 2 MINUTES OF USE WITH MINIMAL POWER OF THE LASER. REPORTEDLY, THE LASER UNIT USED FOR THE THREE LASER FIBERS WAS A LUMENIS P120 WITH SETTINGS OF 0.3/80 JOULES. THE TOTAL ENERGY OF THE THREE LASER FIBERS WERE 4.56 KILOJOULES, 4.56 KILOJOULES, AND 5.0 KILOJOULES, RESPECTIVELY. IT WAS ALSO NOTICED DURING THE PROCEDURE THAT THE FOUR AMPLATZ SUPER STIFF¿ GUIDEWIRES U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6795072 ↗
• MalfunctionAug 15, 2017Break; Break

  NOTE: THIS REPORT PERTAINS TO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2017-01805 FOR THE FLEXIVA 200 TRACTIP LASER FIBER, 3005099803-2017-02444 FOR THE FIRST AMPLATZ SUPER STIFF¿, 3005099803-2017-02445 FOR THE SECOND AMPLATZ SUPER STIFF¿, AND 3005099803-2017-02446 FOR THE THIRD AMPLATZ SUPER STIFF¿. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE FLEXIVA 200 TRACTIP LASER FIBER AND FOUR AMPLATZ SUPER STIFF¿ WERE USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE LASER FIBER BURNED BACK QUICKLY IN 2 MINUTES OF USE WITH MINIMAL POWER OF THE LASER. TWO MORE FLEXIVA 200 TRACTIP LASER FIBER WERE USED AND THE TWO LASER FIBERS BURNED BACK QUICKLY AGAIN IN 2 MINUTES OF USE WITH MINIMAL POWER OF THE LASER. REPORTEDLY, THE LASER UNIT USED FOR THE THREE LASER FIBERS WAS A LUMENIS P120 WITH SETTINGS OF 0.3/80 JOULES. THE TOTAL ENERGY OF THE THREE LASER FIBERS WERE 4.56 KILOJOULES, 4.56 KILOJOULES, AND 5.0 KILOJOULES, RESPECTIVELY. IT WAS ALSO NOTICED DURING THE PROCEDURE THAT THE FOUR AMPLATZ SUPER STIFF¿ GUIDEWIRES U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6795041 ↗