CAPTIVATOR M00561310Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729747680), received between Aug 18, 2017 and Jun 4, 2026 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (12 reports).

2 FDA recall records name this device's identifier, 2 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-1168-2021 · Root cause: Process change control · FDA record ↗

2. Jul 6, 2020Open, Classified

   BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

   Z-2760-2020 · Root cause: Device Design · FDA record ↗

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.

• InjuryJun 4, 2026Break; Entrapment of Device; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026, FOR A POLYP REMOVAL. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO CUT THE POLYP WITH CAUTERY, BUT THE SNARE FAILED TO CUT AND INSTEAD THE LOOP BECAME EMBEDDED IN THE TARGET POLYP. THE SHEATH AND HANDLE OF THE SNARE WERE CUT, AND THE SNARE WAS WITHDRAWN FROM THE SCOPE. A NEW SNARE WAS USED TO CUT THE POLYP AND TO REMOVE THE ORIGINAL SNARE FROM THE PATIENTS TISSUE. THE POLYP SITE WAS CLOSED USING CLIPS. UPON EXAMINATION AFTER THE PROCEDURE, THE PRONG ON THE ORIGINAL SNARE WAS FOUND TO BE LOOSE. THE EVENT RESULTED IN PATIENT PERFORATION AND PROLONGED HOSPITALIZATION BEYOND STANDARD CARE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 25394962 ↗
• MalfunctionDec 23, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  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. IT WAS REPORTED THAT THAT THE STEEL WIRE WAS FRACTURED DURING USE. 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 STABLE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879417 ↗
• MalfunctionNov 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR II SNARE WAS TO BE USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE SCOPING THE PATIENT AND PREPARING TO SNARE A POLYP, THE PATIENT WAS SET UP FOR CAUTERY. THE GROUNDING PAD WAS PLACED ON THE LOWER LEFT SIDE OF THE PATIENT'S BACK, AND THE MACHINE'S INDICATOR LIGHT WAS GREEN, SIGNALING READINESS. HOWEVER, AS SOON AS THE PEDAL WAS PRESSED TO INITIATE POLYP REMOVAL, THE PATIENT SUDDENLY JUMPED AND REPORTED FEELING A SHOCK. THE SNARE WAS DISCARDED AND A NEW SNARE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Electric Shock

  MAUDE report 23466849 ↗
• MalfunctionAug 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE ASCENDING BOWEL FOR POLYP REMOVAL DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE TEAM ATTEMPTED TO USE THE SNARE (PAD WITH GREEN LIGHT), THE PATIENT JUMPED AFTER THE PEDAL WAS PRESSED, INDICATING THAT HE FELT A SHOCK. THE STAFF IMMEDIATELY REMOVED THE SNARE AND REPLACED IT WITH A NEW ONE, WHICH FUNCTIONED PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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: Electric Shock

  MAUDE report 22715082 ↗
• MalfunctionDec 28, 2023Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN THE COLON TO RESECT A POLYP DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE WAS PLUGGED INTO THE GENERATOR FOR ENERGIZATION. THE SNARE WAS THEN LOOPED AROUND THE POLYP AND PHYSICIAN STEPPED ON THE BLUE PEDAL TO ACTIVATE THE ENERGY AND CAUTERIZE THE POLYP. HOWEVER, THE SNARE DID NOT DELIVER ENERGY AND NO CAUTERIZATION WAS MADE. NO VISIBLE PROBLEM WAS NOTED WITH THE CAUTERY PIN AND HANDLE. 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 18414845 ↗
• InjuryJun 12, 2023Entrapment of Device; Mechanical Problem; Failure to Cut; Entrapment of Device; Mechanical Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE NEEDLE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 30MM CAPTIVATOR LARGE OVAL MED STIFF WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PERFORMED ON AN UNKNOWN DATE. ERBE PLATE WAS ATTACHED TO THE PATIENT PRIOR TO THE PROCEDURE USING THE ERBE V102005 DIATHERMY MACHINE SET TO LEFT COLON POLYPECTOMY. THE POLYP WAS RAISED IN ACCORDANCE WITH (B)(6) PROTOCOLS. A SMALL PIECE OF THE POLYP WAS INITIALLY REMOVED WITH THE SNARE. ON THE SECOND ATTEMPT, THE SNARE LOOP WAS EMBEDDED WITHIN THE POLYP AND WOULD NOT OPEN TO BE REMOVED. SEVERAL ATTEMPTS TO OPEN THE SNARE WERE UNSUCCESSFUL. THE LIST CONSULTANT DECIDED TO ABANDON THE PROCEDURE AND CUT THE SNARE AT THE PATIENT'S ANUS, AND THE PATIENT WAS TRANSFERRED TO THE QEUH FOR BOWEL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113552 ↗
• MalfunctionMar 21, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IN AN ATTEMPT TO USE ESU WITH THE SNARE, THE ESU DID NOT WORK. THEY USED A HOT BIOPSY FORCEPS AND IT WORKED. IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582021 ↗
• MalfunctionMar 20, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IN AN ATTEMPT TO USE ESU WITH THE SNARE, THE ESU DID NOT WORK. THEY USED A HOT BIOPSY FORCEPS AND IT WORKED. IT WAS NOT REPORTED WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576355 ↗
• MalfunctionSep 26, 2022Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP WAS IN AN IRREGULAR SHAPE AND THE POLYP COULD NOT BE CUT. NO VISIBLE PROBLEM WAS NOTED WITH THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15487204 ↗
• MalfunctionSep 24, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED IN THE DESCENDING COLON DURING A REMOVAL OF 22MM POLYPS PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE COULD NOT REMOVE THE POLYPOSIS OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15476261 ↗
• MalfunctionJul 21, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE USED DURING AN ENDOSCOPIC MUCOSAL RESECTION AND ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP BROKE. 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 15076866 ↗
• MalfunctionOct 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED FOR POLYP REMOVAL IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CAUTERY CONNECTION PIECE GOT DISLODGED FROM THE SNARE HANDLE AND CAUTERY COULD NO LONGER BE USED. 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 12715489 ↗
• MalfunctionOct 4, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED IN THE FUNDUS OF STOMACH DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE PHYSICIAN COULD NOT USE THE DEVICE TO REMOVE THE PATIENT'S POLYP LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12569626 ↗
• MalfunctionSep 3, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COMPLAINT DEVICE WAS NOT ABLE TO CUT THROUGH THE TARGET POLYP. ALTHOUGH, THE PROCEDURE WAS COMPLETED BY SWITCHING SNARES, IT WAS NOT REPORTED WHAT TYPE OF SNARE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10487870 ↗
• InjuryMar 31, 2020Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE AND OUTSIDE THE PATIENT, THE SNARE WAS PASSED SEVERAL TIMES IN AND OUT OF THE SCOPE AND AT SOME POINT, THE CATHETER GOT DETACHED FROM THE HANDLE LEAVING THE WIRE AT THE TOP EXPOSED. WHEN THE SNARE WAS REMOVED, THE EXPOSED WIRE WAS NOT NOTICED AND WAS PLACED EXTERNALLY ON THE PATIENT. WHILE THE ENDOSCOPIST WAS REMOVING THE SCOPE, HE STEPPED ON THE DIATHERMY PEDAL AND THE SNARE BURNED THE PATIENT'S LEG. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Burn(s)

  MAUDE report 9903894 ↗
• InjuryNov 21, 2019Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Failure to Deliver Energy; Entrapment of Device; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, A HOT SNARE WAS USED TO CAUTERIZE A 6CM TARGET POLYP. THEY HAD STARTED CUTTING THE TARGET POLYP USING COAGULATION WHEN THE DEVICE STOPPED BURNING AND THE SNARE LOOP GOT STUCK IN THE MIDDLE OF THE TARGET POLYP. THE SNARE WAS REMOVED USING A RAT TOOTH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356685 ↗
• MalfunctionJun 7, 2019Failure to Deliver Energy; Entrapment of Device; Failure to Deliver Energy; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT DURING THE REMOVAL OF A LARGE POLYP, THE SNARE FAILED TO COAGULATE. THE SCALPEL GENERATOR AND PATCH WERE REPLACED, HOWEVER, THE SNARE WAS UNABLE TO DELIVER ENERGY. WHEN ATTEMPTING TO RETRIEVE THE SNARE, THE SNARE LOOP WAS STUCK ON THE POLYP AND WAS UNABLE TO BE REMOVED. REPORTEDLY, THE SNARE WAS REMOVED FROM THE PATIENT BY CUTTING THE POLYP WITHOUT CAUTERY (COLD) AND A SECOND CAPTIVATOR SNARE WAS USED TO COMPLETE CUTTING AND COAGULATE IN ORDER TO STOP THE BLEEDING. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8680079 ↗
• InjuryJan 10, 2019Failure to Deliver Energy; Entrapment of Device; Failure to Cut; Failure to Deliver Energy; Entrapment of Device; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL MED STIFF SNARE WAS USED IN THE STOMACH DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN TRYING TO REMOVE THE TARGET POLYP, THE SNARE LOOP WAS TRAPPED IN THE POLYP TISSUE. THE SNARE FAILED TO CUT OR CAUTERIZE THE TISSUE AND THE SNARE COULD NOT BE REMOVED. REPORTEDLY, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND THERE WERE NO VISIBLE ISSUES NOTED WITH THE CAUTERY PIN OR THE DEVICE. AN EMERGENT EXPLORATORY LAPAROTOMY SURGERY WAS PERFORMED TO REMOVE THE SNARE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Code Available

  MAUDE report 8236279 ↗
• MalfunctionMay 24, 2018Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL SNARE WAS USED IN THE CECUM DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP FAILED TO CUT THE TARGET POLYP AND IT WAS NOTED THAT THE DEVICE FAILED TO EXTEND AND RETRACT. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7541310 ↗
• MalfunctionNov 16, 2017Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL SNARE WAS USED IN THE COLON DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE FAILED TO DELIVER CURRENT AND WAS UNABLE TO CUT THE TARGET POLYP. IT WAS NOTED THAT THE CATHETER WAS DETACHED AND THE WIRE INSIDE THE SHEATH WAS BROKEN. 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 Consequences Or Impact To Patient

  MAUDE report 7037057 ↗
• MalfunctionAug 18, 2017Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR LARGE OVAL SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH OF THE DEVICE WAS KINKED AND THERE WAS DIFFICULTY CUTTING THE POLYP, WHICH WAS NOTED TO HAVE DETERIORATED DURING THE PROCEDURE. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6804890 ↗