LightTrail™ Single Use M0068F64540Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08714729939788), received between Dec 10, 2019 and May 11, 2026 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 11, 2026Overheating of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEAD BEGAN TO HEAT UP AND "BURN" UPON CONTACT WITH THE DEVICE. THE MACHINE WAS TURNED OFF, AND THE LEAD WAS REPLACED BEFORE RESUMING THE PROCEDURE. THE DURATION OF THE PROCEDURE WAS EXTENDED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144332 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553015 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT DURING INSERTION, THE FIBER BROKE WITHOUT BEING BENT OR DAMAGED. THERE WERE NO FRAGMENTS THAT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981090 ↗
• MalfunctionOct 28, 2025Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER WAS GRADUALLY DETERIORATED. IT WAS NOTED THAT THE OPERATOR HAD TO CUT THE END OF THE FIBER TWICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE FIBER TIP WAS DETACHED FROM THE FIBER BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408431 ↗
• MalfunctionSep 23, 2025Break; Break

  IT WAS REPORTED THAT THIS FIBER BROKE DURING THE CONTACT TO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23129387 ↗
• InjurySep 23, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER OUTER SHEATH PEELED OFF WHILE PASSING THROUGH THE URETERIC CATHETER. THE DETACHED PIECE WAS RETRIEVED FROM THE BLADDER OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23124373 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE TWO LASER FIBERS BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS IS 2 OF 2 FIBER REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100066 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THIS TWO LASER FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS IS 1OF 2 FIBER REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100065 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE AND THE LASER POINTER THAT COMES OUT WHEN THE EQUIPMENT STARTS. ALSO, NOTED THAT THE BREAK WAS CLOSE TO THE CONNECTOR. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543670 ↗
• InjuryDec 5, 2023Break; Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE TO FRAGMENT KIDNEY STONES, THE FIBER BROKE IN THE SHEATH OF THE FLEXIBLE URETEROSCOPE, CAUSING THE LATTER TO ALSO BREAK. APPROXIMATELY 3CM PIECES OF FIBER REMAINED IN THE PATIENTS RENAL CALYX THUS REQUIRING RECOVERING WHICH CAUSED UNNECESSARY PROLONGATION OF THE PROCEDURE. BOSTON SCIENTIFIC WAS UNABLE TO OBTAIN PATIENT AND PROCEDURE OUTCOME DESPITE GOOD FAITH EFFORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18270446 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (B)(6) 2022 THAT A LIGHTTRAIL SINGLE USE LASER FIBER WAS USED DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE TO TREAT BENIGN PROSTATIC HYPERPLASIA IN THE PROSTATE, PERFORMED (B)(6) 2022. THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE WITH A LASER SETTING OF 18 HERTZ AND 2.2 JOULES. HALFWAY THROUGH THE SURGERY, THE LASER FIBER WAS BROKEN NEAR THE CONNECTOR. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14718191 ↗
• MalfunctionMay 19, 2022Connection Problem; Connection Problem

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2022-02704 FOR THE FIRST LIGHTTRAIL REUSABLE LASER FIBER AND MFR REPORT # 3005099803-2022-02703 FOR THE SECOND LIGHTTRAIL REUSABLE LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT TWO LIGHTTRAIL SINGLE USE LASER FIBERS WERE USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE. DURING THE PROCEDURE, THE TWO LASER FIBERS WOULD NOT WORK. NO EFFECT WAS DONE IN THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437981 ↗
• MalfunctionMay 19, 2022Connection Problem; Connection Problem

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2022-02704 FOR THE FIRST LIGHTTRAIL REUSABLE LASER FIBER AND MFR REPORT # 3005099803-2022-02703 FOR THE SECOND LIGHTTRAIL REUSABLE LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT TWO LIGHTTRAIL SINGLE USE LASER FIBERS WERE USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE. DURING THE PROCEDURE, THE TWO LASER FIBERS HAD CONNECTION ISSUES AND DID NOT WORK, RESULTING IN NO EFFECT TO THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR AND THE FIBER BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437729 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 20, 2022 THAT A LIGHTTRAIL SINGLE USE LASER FIBER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509323 ↗
• MalfunctionSep 16, 2021Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 24, 2021 THAT A LIGHTTRAIL SINGLE USE 600UM LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS AN AURIGA LASER CONSOLE WITH LASER SETTINGS OF 2200 MILLIJOULES AND 18 HERTZ. DURING THE PROCEDURE, THE CONNECTOR OF THE LASER FIBER OVERHEATED AND EVENTUALLY BREAKING THE LASER FIBER. A BURNING SMELL WAS NOTICED BY THE OR STAFF. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 600UM LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484033 ↗
• MalfunctionSep 3, 2021Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LIGHTTRAIL SINGLE USE LASER FIBER WAS USED TO TREAT A BENIGN PROSTATIC HYPERPLASIA (BPH) DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AFTER 10 MINUTES, ENERGY WAS NO LONGER COMING OUT OF THE TIP OF THE FIBER. ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF FIBER BODY FRACTURE AND FRACTURE WITHIN THE FIBER CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421539 ↗
• MalfunctionJul 29, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LIGHTTRAIL SINGLE USE LASER FIBER WAS USED TO TREAT BENIGN PROSTATIC HYPERPLASIA DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE FIBER BROKE CLOSE TO THE FIBER CONNECTOR. NO PART OF THE BROKEN FIBER FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247858 ↗
• MalfunctionJul 7, 2021Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC ON APRIL 14, 2021 THAT A LIGHTTRAIL SINGLE USE 600UM LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE WITH THE LASER SETTINGS OF 2200 MILLIJOULES AND 18 HERTZ. DURING THE PROCEDURE, AFTER 10 MINUTES OF USING, THE FIBER STOPPED WORKING. NO ENERGY WAS COMING OUT OF THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 600UM LASER FIBER. 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 LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127942 ↗
• MalfunctionMay 13, 2021Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A LIGHTTRAIL SINGLE USE 600UM LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE WITH LASER SETTINGS OF 2200 MILLIJOULES AND 18 HERTZ IN ABLATION MODE. DURING PROCEDURE, THE LASER FIBER WORKED FINE. AFTER 10 MINUTES OF USE, THE ENERGY STARTED TO DECREASE AND EVENTUALLY NO ENERGY WAS COMING OUT OF THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 600UM LASER FIBER. 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 LASER FIBER BROKEN WITHIN THE CONNECTOR AND FIBER BODY BROKE. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822470 ↗
• MalfunctionMar 25, 2021Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 3, 2021 THAT A LIGHTTRAIL SINGLE USE 600UM LASER FIBER WAS USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE WITH LASER SETTINGS OF 2.2 JOULES AND 18 HERTZ. IT WAS REPORTED, DURING THE PROCEDURE, AFTER THREE FIRINGS, THE FIBER WAS NOT WORKING WELL. IT APPEARED IT WAS ALMOST BROKEN IN THE PART CLOSER TO THE CONNECTOR OF THE LASER. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 600UM LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11571600 ↗
• MalfunctionOct 21, 2020Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2020-04869 FOR THE AURIGA XL 4007 CONSOLE AND MFR REPORT #3005099803-2020-04875 FOR THE LIGHTTRAIL SINGLE USE LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 24, 2020 THAT AN AURIGA XL 4007 LASER CONSOLE AND A LIGHTTRAIL SINGLE USE 600UM LASER FIBER WERE USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS WORKING FINE TO CUT SOFT TISSUE BUT SUDDENLY THE LASER CONSOLE ALERTED ERROR 1010-PLEASE CONNECT FIBER. THE LASER FIBER WAS UNPLUGGED AND PLUGGED BACK IN. IN THE BEGINNING, EVERYTHING WORKED, AND THEN HALFWAY THROUGH THE CASE, IT SHOWED THE SAME ERROR MESSAGE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 Consequences Or Impact To Patient

  MAUDE report 10714530 ↗
• MalfunctionApr 3, 2020Peeled/Delaminated; Failure to Fire; Peeled/Delaminated; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 20, 2020 THAT A LIGHTTRAIL SINGLE USE 600UM LASER FIBER WAS USED IN A LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS NO ENERGY COMING OUT FROM THE LASER FIBER. REPORTEDLY, THE FIBER WAS NOTED TO BE LAYERED ON ONE SECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 600UM LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9922469 ↗
• MalfunctionMar 20, 2020Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A LIGHTTRAIL SINGLE USE 600UM LASER FIBER WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE WITH LASER SETTINGS OF 3500 MILLIJOULES AND 12 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER CONNECTOR WAS BURNING AND SMOKE WAS COMING OUT FROM IT. UPON REMOVAL OF THE LASER FIBER IT WAS NOTICED THAT THE CONNECTOR WAS VERY HOT. THE LASER CONNECTOR FELL OFF AND SEPARATED FROM THE REST OF THE FIBER. REPORTEDLY, THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861399 ↗
• InjuryDec 26, 2019Break; Misfire; Break; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 2, 2019 THAT A LIGHTTRAIL SINGLE USE 600UM LASER FIBER USED IN A LASER URETEROSCOPY OF STONE PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER SETTINGS USED WAS 6.4 WATTS, 0.8 JOULES AND 12 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT APPROXIMATELY 1 MINUTE AFTER THE FIBER WAS INSERTED INTO THE SCOPE, THE FIBER STARTED TO SPARK WHERE THE DRAPE IS OVER THE PATIENT'S LEG AND THERE WAS A LOUD BANG AND THE FIBER WAS BROKEN. REPORTEDLY, THE OTHER HALF OF THE LASER FIBER WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 600UM LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520392 ↗
• MalfunctionDec 10, 2019Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 5, 2019 THAT A LIGHTTRAIL SINGLE USE 600UM LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WOULD NOT FIT IN THE FIBER PORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 600UM LASER FIBER. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE LASER FIBER TIP DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9445952 ↗