CAPTIVATOR M00562320Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729747857), received between Jul 10, 2017 and Jun 25, 2026 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 19, 2021Class IIOpen, 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 ↗

2. Jul 6, 2020Class IIOpen, 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-2761-2020 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS INTENDED TO BE USED IN THE GASTROINTESTINAL TRACT DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE DID NOT POWER ON, WHICH MADE IT UNABLE TO FUNCTION NORMALLY AND RESULTED IN A MINOR DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE NON BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622772 ↗
• MalfunctionMar 12, 2026Nonstandard Device; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR - SNARES WAS USED TO REMOVE A LARGE POLYP IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE CABLE WAS CONNECTED TO THE SNARE, AND CAUTERY WAS APPLIED TO CUT THROUGH THE POLYP. WHEN THEY OBSERVED THAT THE CUT WAS NOT PROGRESSING AS EXPECTED, THEY STOPPED THE CAUTERY AND INSPECTED THE DEVICE. IT WAS NOTED THAT THE PLASTIC SHEATH HAD SLIGHTLY MELTED AND APPEARED DEFORMED, BUT IT REMAINED ATTACHED. THE PROCEDURE WAS COMPLETED USING 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 24581372 ↗
• MalfunctionMar 12, 2026Nonstandard Device; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR - SNARES WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE CABLE WAS CONNECTED TO THE SNARE AND CAUTERY WAS APPLIED TO CUT THROUGH THE POLYP. WHEN THEY OBSERVED THAT THE CUT WAS NOT PROGRESSING FULLY, THEY STOPPED THE CAUTERY AND INSPECTED THE DEVICE, NOTING THAT THE PLASTIC SHEATH HAD SLIGHTLY MELTED. 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 24580871 ↗
• MalfunctionJun 27, 2025Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CAPTIVATOR SNARE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THERE WAS NO CURRENT DURING CAUTERY RESECTION. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC 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 22344868 ↗
• MalfunctionJun 27, 2025Failure to Deliver Energy; Failure to Deliver Energy

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CAPTIVATOR SNARE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THERE WAS NO CURRENT DURING CAUTERY RESECTION. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC 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 22344866 ↗
• MalfunctionMay 22, 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 (B)(6) 2024. DURING THE PROCEDURE, THE ELECTROCAUTERY DID NOT WORK WHEN ACTIVATED. 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 22072213 ↗
• MalfunctionDec 9, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED IN A CAPTIVATOR PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE PATIENT HAD GASTRIC POLYPS, AND THE POLYPS COULD NOT BE CUT BY USING DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE TO CUT THE POLYPS, WHICH AFFECTED THE PROCEDURE PROGRESS AND CAUSED HIDDEN DANGERS SUCH AS BLEEDING AND UNCLEAN POLYPECTOMY, WHICH INCREASED THE PATIENT'S PAIN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 20878596 ↗
• MalfunctionMar 28, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE POLYPS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE DID NOT CLOSE SMOOTHLY. IT SKIPPED AND CLOSED IN SPURTS, AND THERE WAS NO CONTROL OVER CLOSING THE SNARE. THE PROCEDURE WAS COMPLETED WITH A SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996894 ↗
• MalfunctionFeb 6, 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 WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE WIRE AT THE NOOSE PART BURST WHEN THE HANDLE WAS SLIGHTLY PULLED. 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 18652948 ↗
• MalfunctionJan 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED TO REMOVE POLYP IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHILE PUSHING THE HANDLE, RUST WAS FOUND IN THE METAL POSITION INSIDE THE HANDLE AND ELECTRODE POSITION. 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 18456937 ↗
• MalfunctionNov 9, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE FRACTURED DIRECTLY AFTER IT WAS UNPACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEW SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 14, 2023* THE SHEATH WAS BROKEN, AND IT HAPPENED OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18105671 ↗
• MalfunctionOct 19, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED TO REMOVE A <10 MM INTESTINAL POLYPS IN THE TRANSVERSE COLON DURING A COLD SNARE PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO REMOVE THE INTESTINAL POLYPS THAT WERE FOUND DURING A PAINLESS COLONOSCOPY AT THE ENDOSCOPIC CENTER. HOWEVER, THE PHYSICIAN'S FEEDBACK WAS TRAPPED. THE STEEL WIRE WAS TOO THICK AND NOT SHARP ENOUGH, MAKING IT DIFFICULT TO REMOVE THE LESION. 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 17969557 ↗
• InjuryAug 30, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED DURING AN ENDOSCOPIC MUCOSAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2023. THE LESION WAS A LONG MUCOSAL SWELLING WITH LOBED SURFACE AND A SIZE OF 1.5 CM. DURING THE PROCEDURE, A 27MM SNARE WAS USED BUT WAS UNABLE TO CUT WITH REPEATED ATTEMPTS FOR 20 MINUTES, CAUSING DAMAGE TO THE SURROUNDING MUCOSA. A HEMOSTATIC CLIP WAS USED FOR THE DAMAGE TO THE SURROUNDING MUCOSA. THE PROCEDURE WAS COMPLETED USING A NON-BSC SNARE. THE PATIENT WAS HOSPITALIZED. THE PATIENT'S VITAL SIGNS WERE CLOSELY MONITORED, AND NO ADVERSE REACTIONS OCCURRED. THE PATIENT HAS BEEN DISCHARGED AND THE PATIENT'S CURRENT CONDITION IS STABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17649631 ↗
• MalfunctionAug 15, 2023Failure to Cut; Positioning Problem; Failure to Cut; Positioning Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-04401, 3005099803-2023-04402 AND 3005099803-2023-04403 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN ACCURATELY POSITIONING THE SNARE LOOP AROUND A ONE CENTIMETER POLYP IN THE TRANSVERSE AND SIGMOID COLON. AS A RESULT, THE SNARE WAS UNABLE TO FULLY CUT THE POLYP, LEADING TO AN INCOMPLETE INCISION. HOWEVER, THERE WAS NO PERFORATION. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 17549050 ↗
• MalfunctionJul 18, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED DURING AN ENDOSCOPIC POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE ARE DIFFICULTIES IN CUTTING THE 9CM POLYP WITH THE SNARE IN A SINGLE ATTEMPT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341728 ↗
• MalfunctionJun 30, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED TO RESECT A 0.6CM POLYP IN THE DESCENDING COLON DURING AN INTESTINAL POLYP REMOVAL PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THERE WAS A PROBLEM WITH THE ELECTRIC SNARE'S CLOSURE WHEN IT WAS TIGHTENED. IT WAS NOT POSSIBLE TO COMPLETELY REMOVE THE POLYP, AND THERE WAS EXCESSIVE BURNING OF THE SURROUNDING INTESTINAL MUCOSA. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR MEDIUM OVAL STIFF SNARE. THERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 17243156 ↗
• MalfunctionJun 29, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SNARE COULD NOT BE TIGHTENED WHEN CLOSED. THE ROOT OF THE POLYP COULD NOT BE CUT FROM THE INTESTINAL WALL AND IT WAS REPORTED THAT THE WOUND SURFACE WAS LARGE. THERE WAS NO INTERVENTION REQUIRED TO ADDRESS THE BLEEDING AND THE BLEEDING RESOLVED ON ITS OWN. THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR MEDIUM OVAL . THE PATIENT'S CURRENT CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17224397 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENTS THROUGH THE ARTICLE "ANTIMICROBIAL PROPHYLAXIS IN PATIENTS UNDERGOING ENDOSCOPIC MUCOSAL RESECTION FOR 10- TO 20-MM COLORECTAL POLYPS" WRITTEN BY LINFU ZHENG, ET. AL. THE STUDY AIMED TO INVESTIGATE THE CLINICAL IMPACT OF USING PROPHYLACTIC ANTIBIOTICS DURING THE PERIOPERATIVE PERIOD OF ENDOSCOPIC MUCOSAL RESECTION (EMR) FOR COLORECTAL POLYPS. ACCORDING TO THE LITERATURE, A TOTAL OF 246 PATIENTS WHO MET THE INCLUSION CRITERIA UNDERWENT ENDOSCOPIC MUCOSAL RESECTION AT THE 900TH HOSPITAL OF PLA FOR EMR FROM JANUARY 2016 TO NOVEMBER 2019. IT WAS REPORTED THAT 22 PATIENTS HAD MILD ABDOMINAL PAIN THAT WAS RELIEVED BY A SPASMOLYTIC. IN ADDITION, 21 CASES OF DELAYED BLEEDING WERE OBSERVED AFTER THE EMR PROCEDURE. THE BLEEDING WAS CONTROLLED WITH CLIPS, AND THERE WAS NO SUBSEQUENT BLEEDING. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Abdominal Pain; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17166696 ↗
• MalfunctionJun 8, 2023Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE GASTRIC POLYP RESECTION PROCEDURE IN THE ASCENDING COLON, THE MEDICAL TEAM ENCOUNTERED DIFFICULTY IN USING THE CAPTIVATOR SINGLE-USE POLYPECTOMY SNARES DUE TO ITS SMALL RING SIZE. AFTER THE DEVICE WAS OPENED, IT WAS OBSERVED TO BE IN A STRIP SHAPE. FOLLOWING THE COLD INCISION, THE WOUND BEGAN TO BLEED PROFUSELY AND COULD NOT BE STOPPED WITH IRRIGATION. THE BLEEDING WAS EVENTUALLY STOPPED BY THE APPLICATION OF A CLIP TO THE WOUND AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR CAPTIVATOR MEDIUM OVAL STIFF SNARE. IT WAS NOT REPORTED IF THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED ON JULY 12, 2023, IT WAS REPORTED THAT COLD INCISION WAS PERFORMED TO RESECT A 1CM POLYP, EVEN THOUGH THE SNARE LOOP DID NOT FULLY EXTEND, AND IT WAS THE ORIGINAL DEVICE THAT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086023 ↗
• MalfunctionDec 20, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE NURSE USED THE SNARE FOR THERMAL CUTTING, IT WAS FOUND THAT THE DEVICE COULD NOT CONDUCT ELECTRICITY. AFTER THE WOUND CUTTING FOR THE PATIENT, ELECTRIC CAUTERY AND BLOOD COAGULATION DIDN'T WORK AND THERE WAS BLEEDING OF THE WOUND. THE PHYSICIAN CLOSED THE WOUND WITH A TITANIUM CLIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 26, 2022: THE SNARE WAS USED TO REMOVE A 1.8 - 2CM SIZE OF POLYP IN THE SIGMOID FLEXURE DURING AN ELECTRO RESECTION BY COLONOSCOPY PROCEDURE. THE PATIENT DID NOT HAVE ANY HISTORY OF COAGULOPATHY/BLEEDING DISORDERS AND THE PATIENT WAS NOT ON ANY ANTICOAGULANTS. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD AND THERE WERE NO VISIBLE PROBLEMS NOTED WITH THE CAUTERY PINS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16013652 ↗
• MalfunctionSep 9, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS TO USED REMOVE INTESTINAL POLYPS IN THE INTESTINAL TRACT DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE TRAP WAS CONNECTED TO THE ELECTRODE, BUT NO REACTION WAS OBSERVED WHEN CUTTING WITH ELECTRICITY. 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 15393287 ↗
• MalfunctionJul 11, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED TO REMOVE GASTRIC POLYPS IN THE STOMACH DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE WAS UNABLE TO REMOVE THE POLYPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER BRAND OF SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976440 ↗
• MalfunctionJul 7, 2022Electrical /Electronic Property Problem; Failure to Cut; Electrical /Electronic Property Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED TO REMOVE A 1CM POLYP IN THE LARGE INTESTINE DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS FOUND THAT THE THERMAL CUTTING WAS INEFFECTIVE AFTER INTESTINAL ADENOMA WAS INJECTED INTO THE SWELLING, AND THE ADENOMA COULD NOT BE REMOVED NORMALLY. THERE WAS ELECTRICAL CURRENT TRANSMITTED BUT IT WAS SUBOPTIMAL. NO PROBLEMS FOUND IN THE CAUTERY PIN. THE PROCEDURE WAS COMPLETED WITH A NON-BSC 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 14945416 ↗
• InjuryMay 5, 2022Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED TO REMOVE POLYPS IN THE COLON DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE DEVICE COULD NOT BE CLOSED AND THE DEVICE WAS UNABLE TO COMPLETELY CUT OFF THE TARGET POLYP DURING TREATMENT, "RESULTING IN EXCESSIVE BURNS OF THE SURROUNDING INTESTINAL MUCOSA AND EASY INFECTION." THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR SNARE. THE BURNS WERE RESOLVED BY USING CLIPS. THERE WAS NO REPORTED INFECTION, IT WAS REPORTED THAT THE PHYSICIAN USED THE CLIP TO PREVENT INFECTION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 14287931 ↗
• MalfunctionApr 29, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL STIFF SNARE WAS USED IN THE COLON TO REMOVE COLONIC MUCOSAL POLYPS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE DEVICE WAS TOO HARD AND BRUISED THE NORMAL TISSUE AROUND THE LESION. UPON STRANGULATION, THEY EXPERIENCED DIFFICULTY IN CUTTING THE TARGET POLYPS. THE DEVICE WAS TOO HARD, TOO BLUNT AND TOO THICK THAT THE MUCOSAL MUSCLE LAYER WAS INJURED. THE PROCEDURE WAS COMPLETED USING CLIPS. 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: Unspecified Tissue Injury

  MAUDE report 14251986 ↗