CAPTIVATOR II M00561190Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729861263), received between Oct 22, 2018 and Sep 25, 2024 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 19, 2021Open, Classified

   Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.

   Z-1169-2021 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Break; 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 A CAPTIVATOR SNARE DEVICE WAS USED FOR POLYPECTOMY DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE LOOP WIRE WAS BROKEN WHILE PERFORMING HOT POLYPECTOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306827 ↗
• MalfunctionSep 13, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR CAPTIVATOR II SNARE WAS USED IN THE SIGMOID COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE ELECTROCAUTORY PART OF HOT SNARE WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR II SNARE. 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 20217617 ↗
• MalfunctionSep 2, 2024Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO THE ONE OF THREE CAPTIVATOR SNARES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE CAPTIVATOR SNARE WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE PATIENT'S BODY, BUT IT COULD NOT BE POWERED ON. ADDITIONALLY, THE SAME PROBLEM OCCURRED WITH THE OTHER TWO CAPTIVATOR SNARES. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118455 ↗
• MalfunctionSep 2, 2024Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE ONE OF THREE CAPTIVATOR SNARES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE CAPTIVATOR SNARE WERE USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE PATIENT'S BODY, BUT IT COULD NOT BE POWERED ON. ADDITIONALLY, THE SAME PROBLEM OCCURRED WITH THE OTHER TWO CAPTIVATOR SNARES. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118412 ↗
• MalfunctionMar 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 10MM CAPTIVATOR II ROUND STIFF SNARE WAS EXAMINED DURING A ROUTINE PRODUCT CHECK PERFORMED ON AN UNKNOWN DATE. DURING A ROUTINE PRODUCT CHECK, THE NURSE CLINICIAN FOUND A PARTICLE IN THE UNOPENED PACKAGING. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518137 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 25MM CAPTIVATOR II ROUND STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON DECEMBER 8, 2022. DURING THE PROCEDURE, THE PIN CAME OFF. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16107724 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 25MM CAPTIVATOR II ROUND STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6)2022 . DURING THE PROCEDURE, THE PIN CAME OFF. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16107606 ↗
• MalfunctionJan 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 25MM CAPTIVATOR II ROUND STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PIN CAME OFF. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR II SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16107598 ↗
• MalfunctionMar 28, 2022Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 25MM CAPTIVATOR II ROUND STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTUATE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE CAUTERY PIN WAS DETACHED. PLEASE SEE BLOCK FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934401 ↗
• MalfunctionJan 13, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 25MM ROUND STIFF CAPTIVATOR II SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PREPARATION AND OUTSIDE THE PATIENT THERE WAS A CONNECTION PROBLEM WITH THE ACTIVE CORD CONNECTOR. IT WAS NOTICED THAT THE CAUTERY PIN WAS DETACHED AND THE WIDTH OF THE PIN WAS CLOSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252186 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-25MM ROUND STIFF SNARE WAS USED TO REMOVE A POLYP IN THE INTESTINAL TRACT DURING A REMOVAL OF INTESTINAL POLYPS PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SNARE LOOP WAS FRACTURED WHILE REMOVING THE POLYPS. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND 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 13114347 ↗
• MalfunctionJul 6, 2021Electrical /Electronic Property Problem; Failure to Cut; Electrical /Electronic Property Problem; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2021-03236, 3005099803-2021-03237, 3005099803-2021-03238 AND 3005099803-2021-03239 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-25MM ROUND STIFF SNARE WAS TO BE USED IN THE COLON TO REMOVE A MASS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, PHYSICIAN ATTEMPTED TO RESECT A LESION FIRST USING A CAPTIVATOR II 15MM (M00561230), A SECOND CAPTIVATOR II 15MM (M00561230), THEN A CAPTIVATOR II 25MM (M00561190), AND LASTLY A CAPTIVATOR CRESCENT 27MM (M00562370). THE LESION WAS NOTED TO BE FIBROTIC. NONE OF THE SNARES WOULD CUT EFFICIENTLY AND SEEMED TO ONLY "HEAT UP" AT THE TIP OF THE SNARE. THE PHYSICIAN COULD BLANCH THE TISSUE USING THE TIP, BUT WHEN THE SNARE WAS OPENED AROUND THE LESION, IT DID NOT SEEM TO HAVE ANY CUTTING POWER IN THE LOOP OF THE SNARE. THE NURSE/TECHS TRIED MULTIPLE SNARES, CHANGED OUT THE GROUND PADS, ACTIVE CORDS, AND GENERATORS. ADDITIONALLY, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE AND NO ISSUES WER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120834 ↗
• MalfunctionApr 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II ROUND STIFF SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE THE CAUTERY PIN WAS DETACHED FROM THE DEVICE WHEN ATTEMPTING TO ATTACH THE ACTIVE CORD. REPORTEDLY, THERE WERE NO ISSUES PRESENT UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627138 ↗
• MalfunctionDec 16, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-25MM ROUND STIFF SNARE WAS USED TO REMOVE POLYPS DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WOULD NOT CUT THROUGH THE TARGET POLYP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11021052 ↗
• MalfunctionNov 5, 2020Electrical /Electronic Property Problem; Failure to Cut; Electrical /Electronic Property Problem; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-05064 AND 3005099803-2020-05065 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-25MM ROUND STIFF SNARE WAS USED TO REMOVE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE FIRST SNARE WORKED UPON FIRST CUT BUT THEN FAILED TO CAUTERIZE UPON FURTHER ATTEMPTS. THE GENERATOR WAS SWITCHED FOR ANOTHER AND THE SAME SNARE WAS USED, BUT DID NOT RESULT IN A SUCCESSFUL CUT. A SECOND CAPTIVATOR SNARE WITH THE SAME SIZE WAS OPENED AND IT WORKED FOR TWO CUTS BUT THEN, IT ALSO FAILED AFTER. A THIRD CAPTIVATOR SNARE OF A DIFFERENT SIZE WAS THEN USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791284 ↗
• MalfunctionNov 5, 2020Electrical /Electronic Property Problem; Failure to Cut; Electrical /Electronic Property Problem; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-05064 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-25MM ROUND STIFF SNARE WAS USED TO REMOVE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE FIRST SNARE WORKED UPON FIRST CUT BUT THEN FAILED TO CAUTERIZE UPON FURTHER ATTEMPTS. THE GENERATOR WAS SWITCHED FOR ANOTHER AND THE SAME SNARE WAS USED, BUT DID NOT RESULT IN A SUCCESSFUL CUT. A SECOND CAPTIVATOR SNARE WITH THE SAME SIZE WAS OPENED AND IT WORKED FOR TWO CUTS BUT THEN, IT ALSO FAILED AFTER. A THIRD CAPTIVATOR SNARE OF A DIFFERENT SIZE WAS THEN USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791228 ↗
• MalfunctionAug 18, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-25MM ROUND STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAS HAD MULTIPLE SNARES OF THIS TYPE THAT HAD ISSUES WITH CUTTING THROUGH THE TARGET POLYPS WHEN CONNECTED TO CAUTERY. REPORTEDLY, THEY DID NOT NOTE ANY SIGNS OF TISSUE BLANCHING. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND THERE WERE NO VISIBLE ISSUES NOTED WITH THE CAUTERY PIN. THE PHYSICIAN TRIED TO UNPLUG AND RECONNECT THE SNARE BUT THEY STILL ENCOUNTERED THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420016 ↗
• MalfunctionAug 18, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-25MM ROUND STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAS HAD MULTIPLE SNARES OF THIS TYPE THAT HAD ISSUES WITH CUTTING THROUGH THE TARGET POLYPS WHEN CONNECTED TO CAUTERY. REPORTEDLY, THEY DID NOT NOTE ANY SIGNS OF TISSUE BLANCHING. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND THERE WERE NO VISIBLE ISSUES NOTED WITH THE CAUTERY PIN. THE PHYSICIAN TRIED TO UNPLUG AND RECONNECT THE SNARE BUT THEY STILL ENCOUNTERED THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10419855 ↗
• MalfunctionAug 4, 2020Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-25MM ROUND STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE DID NOT FEEL OR APPEAR TO BE CUTTING THE TISSUE ADEQUATELY. ALSO, THE SNARE DID NOT RETRACT INTO THE CATHETER FULLY WHEN TRYING TO CLOSE THE HANDLE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED, HOWEVER IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020*** THERE WERE NO OTHER ISSUES NOTED WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WHICH WAS ONE OF THE LEGACY MODELS OF THE SNARE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10364125 ↗
• MalfunctionJul 21, 2020Failure to Cut; Difficult to Open or Close; Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL FLEXIBLE SNARE WAS USED TO REMOVE A LESS THAN 1 CM POLYP IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WOULD NOT CUT THROUGH THE LESS THAN 1 CM TARGET POLYP SMOOTHLY DUE TO THE RESISTANCE FELT WHEN ACTUATING DURING BOTH HOT AND COLD POLYPECTOMY. THERE WAS NO TACTILE FEEDBACK ACCORDING TO THE NURSE/ TECH. THEY CHECKED THE CAUTERY SETTINGS, OPENED AND CLOSED THE SNARES AS A TEST TO ENSURE THEY WERE FUNCTIONING PROPERLY. THEY ALSO MADE SURE THAT THE CAUTERY PORT WAS CONNECTED SECURELY TO THE SNARES AND TRIED BOTH HOT AND COLD. REPORTEDLY, NO VISIBLE ISSUES WAS NOTED WITH THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE AND STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302592 ↗
• MalfunctionJun 11, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II-25MM ROUND STIFF SNARE WAS PREPARED FOR USE IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THERE WERE TWO HAIRS INSIDE THE UNOPENED STERILE POUCH OF THE DEVICE. REPORTEDLY, THE INNER SEAL PACKAGE WAS NOT COMPROMISED AND THERE WAS NO DAMAGE NOTED TO THE INNER STERILE POUCH OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687641 ↗
• InjuryOct 22, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II ROUND STIFF SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE WAS DEPLOYED FROM THE END OF THE SCOPE AND A FREE PIECE OF METAL WAS FOUND LAYING ON THE PATIENT'S TISSUE. THE FREE PIECE OF METAL WIRE WAS RETRIEVED USING THE SAME SNARE AND WAS BROUGHT OUT THROUGH THE SCOPE. THE SCOPE WAS TESTED FOR LEAKS AND PASSED ALL THE LEAK TESTS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7991244 ↗