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OptiFlex M0063903010Recalls & reported problems

Boston Scientific Corporation · Nitinol Stone Retrieval Basket · Class 2

Quick summary

This Boston Scientific OptiFlex nitinol stone retrieval basket is a wire basket used to grab and remove kidney or ureteral stones. The 35 reports mostly describe the basket breaking during a procedure, sometimes leaving a tip that had to be retrieved from the patient, plus baskets that would not open or close and handles that stopped moving. There are 34 malfunctions, 1 injury and no deaths. Most reports say the patient was not harmed. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
35
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08714729772859), received between Feb 8, 2017 and May 12, 2023 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Break” (31 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

Device problems

  • Break31
  • Difficult to Open or Close10
  • Material Deformation8
  • Detachment of Device or Device Component3
  • Use of Device Problem2
  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Consequences Or Impact To Patient28
  • No Clinical Signs, Symptoms or Conditions5
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

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

  • MalfunctionMay 12, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTI-FLEX BASKET STERILE POUCH WAS FOUND WITH A FOREIGN MATTER ON APRIL 24, 2023. DURING PREPARATION, IT WAS OBSERVED THAT THERE WAS A DEBRIS IN THE STERILE PACKAGING OF AN OPTI-FLEX BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16918322 ↗
  • InjuryOct 13, 2022Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, A TIP OF THE BASKET BROKE OFF AND HAD TO BE RETRIEVE FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15594478 ↗
  • MalfunctionSep 13, 2021Break; Difficult to Open or Close; Break; Difficult to Open or Close

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE KIDNEY DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, THE BASKET FAILED TO OPEN WHEN ATTEMPTING TO CAPTURE THE STONE. WHEN THE BASKET WAS REMOVED FROM THE PATIENT, HANDLE WAS ACTUATED AND FOUND THE BASKET DID OPEN OR CLOSE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12464162 ↗
  • MalfunctionFeb 22, 2021Break; Difficult to Open or Close; Break; Difficult to Open or Close

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. AFTER OPENING THE PACKAGE, THE HANDLE WAS ACTUATED AND FOUND THE BASKET DOES NOT OPEN OR CLOSE. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11362157 ↗
  • MalfunctionFeb 4, 2021Break; Difficult to Open or Close; Material Deformation; Break; Difficult to Open or Close; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE BASKET OPENED INSIDE THE PATIENT BUT FAILED TO CLOSE. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS DETACHED/SEPARATED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11280754 ↗
  • MalfunctionNov 2, 2020Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation; Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS TO BE USED IN THE KIDNEY DURING A FLEXIBLE URETEROSCOPE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BASKET FAILED TO OPEN. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THE INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS DETACHED/SEPARATED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10770534 ↗
  • MalfunctionOct 12, 2020Break; Use of Device Problem; Difficult to Open or Close; Material Deformation; Break; Use of Device Problem; Difficult to Open or Close; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROLITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THE INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10666726 ↗
  • MalfunctionJun 10, 2020Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE LEFT KIDNEY DURING A FIBEROPTIC TRANSURETHRAL LITHOTRIPSY (F-TUL) PROCEDURE PERFORMED ON (B)(6). ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE HANDLE SUDDENLY BECAME HARD AND UNABLE TO MOVE. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10140463 ↗
  • MalfunctionJun 10, 2020Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE OPTIFLEX BASKET WAS TESTED. THE BASKET WAS FOUND TO HAVE OPENED AND CLOSED AT FIRST BUT IT FAILED TO OPEN ON THE SECOND TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLEX BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE PULL WIRE IS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT. PLEASE SEE FOR FULL INVESTIGATION DETAILS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10138275 ↗
  • MalfunctionMar 30, 2020Break; Difficult to Open or Close; Material Deformation; Break; Difficult to Open or Close; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A URETEROLITHIASIS PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HANDLE WHEEL OF THE BASKET COULD NOT BE ROTATED, AND THE PHYSICIAN'S HAND WAS HURT WHILE ACTUATING AS A RESULT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE PULL WIRE WAS BROKEN; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9900520 ↗
  • MalfunctionMar 2, 2020Break; Use of Device Problem; Material Deformation; Break; Use of Device Problem; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY (F-URS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, PRIOR TO PROCEDURE, THE DEVICE WAS INSPECTED AND FOUND THE BASKET FAILED TO OPEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY STABLE. THE INVESTIGATION FOUND THAT THE PULL WIRE WAS DETACHED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9774940 ↗
  • MalfunctionJan 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE URETER DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET BECAME UNABLE TO OPEN AND WAS STUCK CLOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLEX BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; PULL WIRE DETACHED/SEPARATED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9590828 ↗
  • MalfunctionNov 1, 2019Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. REPORTEDLY, THE HANDLE WOULD NOT MOVE AT ALL. ANOTHER OPTIFLEX BASKET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS; PULL WIRE BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9268151 ↗
  • MalfunctionSep 20, 2019Break; Difficult to Open or Close; Material Deformation; Break; Difficult to Open or Close; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN THE KIDNEY DURING AN RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS, PULL WIRE DETACHED/SEPARATED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9100757 ↗
  • MalfunctionJul 26, 2019Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation; Detachment of Device or Device Component; Difficult to Open or Close; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED IN A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET FAILED TO OPEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INVESTIGATION RESULTS REVEALED THAT THE PULL WIRE WAS DETACHED; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8831032 ↗
  • MalfunctionApr 30, 2019Break; Difficult to Open or Close; Material Deformation; Break; Difficult to Open or Close; Material Deformation

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OPTI FLEX RETRIEVAL BASKET WAS USED IN THE RIGHT URETER FOR A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET WAS NOT ABLE TO OPEN DUE TO THE HANDLE BEING UNABLE TO MOVE AFTER BEING UTILIZED TWO TO THREE TIMES. THE BASKET WAS REPORTED TO BE IN A CLOSED POSITION WHEN IT STOPPED WORKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTI FLEX RETRIEVAL BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PULL WIRE BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8566626 ↗
  • MalfunctionJan 8, 2019Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A OPTIFLEX RETRIEVAL BASKET WAS USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED IN THE RIGHT KIDNEY ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE HANDLE OPERATION USING THE PRODUCT CONTROL WHEEL DID NOT MOVE DURING THE TEST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLEX RETRIEVAL BASKET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PULL WIRE, DETACHED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8228511 ↗
  • MalfunctionOct 31, 2018Break; Difficult to Open or Close; Break; Difficult to Open or Close

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX RETRIEVAL BASKET WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018 THROUGH RETROGRADE ACCESS IN THE KIDNEY TO TREAT STONES. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS REPORTED THAT THE HANDLE OF THE BASKET WAS NOT WORKING AND THE BASKET COULD NOT BE OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLEX BASKET. THERE WAS NO SERIOUS INJURY NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PULL WIRE DETACHED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8025557 ↗
  • MalfunctionAug 10, 2018Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX¿ RETRIEVAL BASKET WAS USED IN THE URETER DURING A LEFT LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET WAS UNABLE TO OPEN OR CLOSE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTI-FLEX BASKET. 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". THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION FINDINGS OF PULL WIRE; BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7774834 ↗
  • MalfunctionJun 15, 2018Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX¿ BASKET WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE BASKET WAS UTILIZED FOR OPENING AND CLOSING FOR ABOUT TWENTY TIMES, IT WOULD NO LONGER OPEN OR CLOSE. IT WAS REPORTED THAT IT SEEMED THAT THE HANDLE AND THE SHAFT PART GOT SEPARATED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT 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 "GOOD".

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7607741 ↗
  • MalfunctionJun 15, 2018Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX¿ BASKET WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE BASKET WAS UTILIZED FOR OPENING AND CLOSING FOR ABOUT TWENTY TIMES, IT WOULD NO LONGER OPEN OR CLOSE. IT WAS REPORTED THAT IT SEEMED THAT THE HANDLE AND THE SHAFT PART GOT SEPARATED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT 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 "GOOD".

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7607689 ↗
  • MalfunctionJun 14, 2018Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX¿ BASKET WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE BASKET WAS UTILIZED FOR OPENING AND CLOSING FOR ABOUT TWENTY TIMES, IT WOULD NO LONGER OPEN OR CLOSE. IT WAS REPORTED THAT IT SEEMED THAT THE HANDLE AND THE SHAFT PART GOT SEPARATED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT 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 "GOOD".

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7602018 ↗
  • MalfunctionMar 14, 2018Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX¿ BASKET WAS USED IN A URETEROSCOPY (URS) STONE REMOVAL PROCEDURE TO HELP TREAT CALYCEAL CALCULI LOCATED IN THE UPPER URETER, PELVIC AND CALYX, ON (B)(6) 2018. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE OPTIFLEX BASKET WAS UTILIZED TO RETRIEVE A 2 CM STONE. HOWEVER, THE BASKET COULD NOT OPEN OR CLOSE FREELY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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." THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PULL WIRE BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7339793 ↗
  • MalfunctionMar 8, 2018Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLEX¿ NITINOL RETRIEVAL BASKET WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE WITH STONE REMOVAL PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET COULD NOT BE OPENED AND CLOSED FREELY. THE STONE WAS WITHIN 2 CM AND WAS LOCATED IN UPPER URETER, RENAL PELVIS AND CALYX. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PULL WIRE BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7324504 ↗
  • MalfunctionFeb 12, 2018Break; Break

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIPLEX¿ BASKET WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE OPTIFLEX BASKET COULD NOT BE USED DUE TO A BROKEN PULL WIRE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7263363 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.