CAPTIVATOR M00562450Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 08714729747970), received between Nov 3, 2017 and Sep 4, 2026 — classified as 3 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (42 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1168-2021 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612248 ↗
• MalfunctionSep 4, 2026Failure to Deliver Energy

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611578 ↗
• MalfunctionJan 30, 2026Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARES WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT WHEN THE PHYSICIAN APPLIED CAUTERY AND CLOSED THE SNARE, A SMALL PIECE OF POLYP, APPEARED TO BECOME CAUGHT IN THE SHEATH, WHICH PREVENTED THE SNARE FROM FULLY CUTTING THE POLYP. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222024 ↗
• MalfunctionJan 16, 2026Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WAS POSITIONED AROUND THE POLYP, BUT WHEN THE PEDAL WAS ACTIVATED, THE SNARE UNABLE TO CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093496 ↗
• MalfunctionDec 23, 2025Failure to Deliver Energy; Material Twisted/Bent; Failure to Deliver Energy; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED IN THE ASCENDING COLON DURING A COLONOSCOPY PROCEDURE FOR SCREENING PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CAUTERY WAS ATTACHED, BUT THE SNARE DID NOT WORK. THE CAUTERY WAS CHECK AS WELL AS THE CONNECTION, BUT THE SNARE CAUTERY WOULD NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878690 ↗
• MalfunctionDec 9, 2025Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE DEVICE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE FOR LARGE POLYP REMOVAL PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE WAS ACTIVATED BUT DID NOT CUT THROUGH THE TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER CAPTIVATOR SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757831 ↗
• MalfunctionNov 26, 2025Failure to Deliver Energy; Retraction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Retraction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A POLYP USING THE 13-HEX SNARE DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE DID NOT WORK AS INTENDED. THERE WAS NO CAUTERY CONNECTION. THE ERBE CORD WAS PLUGGED INTO THE SNARE HANDLE. WHEN THE CORD WAS REMOVED, THE CAUTERY COMPONENT OF THE SNARE BROKE OFF. THE STAFF HAS ISSUES CLOSING THE SNARE IN ORDER TO REMOVE IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658739 ↗
• MalfunctionNov 12, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A BENIGN NON-PEDUNCULATED POLYPS 5-MM POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE USING A SINGLE-USE ELECTROCAUTERY SNARE, IT WAS FOUND THAT THE BLADE WAS VERY DULL AND UNABLE TO REMOVE THE POLYP. THE DEVICE WAS IMMEDIATELY REPLACED, AND THE PATIENTS POLYP WAS THEN SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536667 ↗
• MalfunctionNov 12, 2025Mechanical Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE RECTUM DURING A RECTAL POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTICED THAT THE CAPTIVATOR SNARE COULD NOT BE FULLY OPENED AND WAS NOT ABLE CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533098 ↗
• MalfunctionOct 8, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE DEVICE WAS USED FOR A POLYP IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER CUTTING A POLYP, WHEN THE TECHNICIAN WAS ABOUT TO CUT THE SECOND POLYP, THE METAL CONNECTOR OF THE ELECTROSURGICAL GENERATOR ON THE HANDLE SUDDENLY FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE 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 23246236 ↗
• MalfunctionAug 27, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE ENERGIZATION WAS UNSUCCESSFUL. THE SNARE WAS SECURELY CONNECTED TO THE ACTIVE CORD, AND NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903412 ↗
• MalfunctionAug 5, 2025Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE DESCENDING COLON FOR TISSUE RESECTION DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SNARE DID NOT DEPLOY FROM THE CATHETER DESPITE MULTIPLE ATTEMPTS, RESULTING IN THE LOOP BEING UNABLE TO CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715075 ↗
• MalfunctionMay 19, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE DEVICE WAS USED FOR REMOVAL OF COLORECTAL POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN TAKING OUT THE PRODUCT FROM THE PACKAGING, IT WAS NOTICED THAT THE PLASTIC-SEALED BAG PACKAGING HAD ALREADY BEEN OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 22047756 ↗
• MalfunctionMay 6, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A PEDUNCULATED POLYP IN THE DESCENDING COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WAS UNABLE TO DELIVER ENERGY. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. THERE WAS NO ATTEMPT TO COLD CUT THE POLYP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968081 ↗
• MalfunctionMar 24, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE STOMACH DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, UPON CLOSING THE SNARE DURING POLYPECTOMY, PHYSICIAN WANTED TO CARRY OUT HOT POLYPECTOMY AND REALIZED THAT THERE WAS NO ENERGY TRANSMITTED. NURSES AND DOCTOR TRIED TO CHECK THE ERBE MACHINE AND RESET THE MACHINE, ATTEMPTED TO RECONNECT THE BANANA PLUG, NONE OF THE ACTIONS RESOLVED THE PROBLEM. 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 21680567 ↗
• MalfunctionMar 18, 2025Failure to Deliver Energy; Entrapment of Device; Failure to Deliver Energy; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR - SNARE WAS USED FOR A POLYPECTOMY PROCEDURE AT THE COLON PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A LARGE POLYP WAS BEING REMOVED, BUT THE SNARE GOT STUCK AROUND THE POLYP AND WAS UNABLE TO CUT. THE CAUTERY UNIT WAS EXCHANGED, AND THE SNARE STILL DID NOT WORK. THE PHYSICIAN WAS ABLE TO REMOVE THE LOOP FROM AROUND THE POLYP BY MANEUVERING. 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 21632134 ↗
• MalfunctionFeb 6, 2025Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR DEVICE WAS USED IN COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE NURSES REPORTED THAT PHYSICIANS WERE HAVING ISSUES WITH THE 13MM HEX DEVICE. IT WAS NOT CUTTING THROUGH POLYPS EFFECTIVELY OR CLEANLY, AND IT ALSO FAILED TO CAUTERIZE WHEN CONNECTED TO THE CAUTERY UNIT. THE PROCEDURE WAS COMPLETED WITH THE SAME CAPTIVATOR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321624 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL HEXAGONAL STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THREADED THE SNARE THROUGH THE SCOPE AND OPENED IT TO CAPTURE A POLYP. WHEN ATTEMPTED TO CLOSE THE SNARE AROUND THE POLYP, THEY HEARD AND FELT A SNAP. IT WAS UNABLE TO CLOSE TO REMOVE THE POLYP FROM THE SCOPE, SO PULLED THE SNARE OUT WHILE IT WAS STILL OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SMALL HEXAGONAL STIFF SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614883 ↗
• MalfunctionOct 9, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE HEXAGONAL LOOP NUMBER 13 WAS BLUNT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406148 ↗
• MalfunctionApr 4, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE ASCENDING COLON FOR SCREENING DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP COULD NOT FULLY CUT THOUGH THE POLYP EVEN THOUGH CAUTERY HAS BEEN APPLIED. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN. 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 19047441 ↗
• MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE ACTIVE CORD CONNECTION PART WAS SEPARATED BEFORE USAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993394 ↗
• MalfunctionMar 25, 2024Failure to Cut; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01112 FOR THE FIRST CAPTIVATOR SNARE, 3005099803-2024-01113 FOR THE SECOND CAPTIVATOR SNARE, AND 3005099803-2024-01114 FOR THE THIRD CAPTIVATOR SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A POLYP IN THE ASCENDING COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WOULD NOT CUT. THERE WERE SIGNS OF BLANCHING, AND THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. NO PROBLEMS WITH THE CAUTERY PIN. HOWEVER, THEY FELT RESISTANCE WHEN ACTUATING. THEY TRIED TWO SNARES AND CONNECTED TO A DIFFERENT CAUTERY MACHINE, BUT IT STILL WOULD NOT CUT THROUGH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18972589 ↗
• MalfunctionMar 25, 2024Failure to Cut; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01112 FOR THE FIRST CAPTIVATOR SNARE, 3005099803-2024-01113 FOR THE SECOND CAPTIVATOR SNARE, AND 3005099803-2024-01114 FOR THE THIRD CAPTIVATOR SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A POLYP IN THE ASCENDING COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WOULD NOT CUT. THERE WERE SIGNS OF BLANCHING, AND THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. NO PROBLEMS WITH THE CAUTERY PIN. HOWEVER, THEY FELT RESISTANCE WHEN ACTUATING. THEY TRIED TWO SNARES AND CONNECTED TO A DIFFERENT CAUTERY MACHINE, BUT IT STILL WOULD NOT CUT THROUGH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18972038 ↗
• MalfunctionMar 25, 2024Failure to Cut; Failure to Cut

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER FOR THE FIRST CAPTIVATOR SNARE, 3005099803-2024-01113 FOR THE SECOND CAPTIVATOR SNARE, AND 3005099803-2024-01114 FOR THE THIRD CAPTIVATOR SNARE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A POLYP IN THE ASCENDING COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WOULD NOT CUT. THERE WERE SIGNS OF BLANCHING, AND THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD. NO PROBLEMS WITH THE CAUTERY PIN. HOWEVER, THEY FELT RESISTANCE WHEN ACTUATING. THEY TRIED TWO SNARES AND CONNECTED TO A DIFFERENT CAUTERY MACHINE, BUT IT STILL WOULD NOT CUT THROUGH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18971884 ↗
• MalfunctionFeb 12, 2024Failure to Cut; Detachment of Device or Device Component; Failure to Cut; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE A 10MM POLYP IN THE COLON DURING A COLONOSCOPY, POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SNARE WAS UNABLE TO CUT THE TARGET POLYP AND THE SHEATH SNAPPED. THE DEVICE WAS SECURELY ATTACHED TO THE ACTIVE CORD. THEY ATTEMPTED TO COLD SNARE THE POLYP; HOWEVER, IT WAS NOT STRONG ENOUGH TO CUT THE POLYP. 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 18691317 ↗