SENSATION Short Throw M00562690Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729748106), received between Jan 12, 2017 and Aug 7, 2026 — classified as 4 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (13 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 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-1170-2021 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Failure to Deliver Energy

  It was reported to Boston Scientific Corporation that a Sensation Snare was used in the gastrointestinal tract during a polypectomy procedure performed on (b)(6) 2026.During the procedure, upon advancing to target anatomy the device was unable to deliver any electrical current. The generator was checked and replaced with another but still no current observed. 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 50177005 ↗
• MalfunctionMay 29, 2026Failure to Deliver Energy; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SENSATION SNARE WAS USED IN THE COLON FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE THE ACTIVE CORD OF THE SNARE FELT INCONSISTENT AND FAILED TO DELIVER ENERGY AND ALSO PRESENTED RETRACTION ISSUES. PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334373 ↗
• InjuryMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE PHYSICIAN FOUND A POLYP, THE SNARE LOOP DETACHED COMPLETELY OF THE WORKING LENGTH. AS A RESULT, RAT TOOTH FORCEPS WAS REQUIRED TO RETRIEVE THE PIECE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303095 ↗
• MalfunctionMay 14, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE WAS INTENDED TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. PRIOR TO THE PROCEDURE, UPON REMOVAL FROM PACKAGING THE SNARE LOOP BROKE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176419 ↗
• MalfunctionApr 16, 2026Retraction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE DEVICE WAS USED IN THE COLON DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SNARE WOULD NOT COMPLETELY CLOSE AFTER ITS FIRST OPENING. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF THE CAUTERY PIN DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899181 ↗
• MalfunctionApr 14, 2026Retraction Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE DEVICE WAS USED IN THE COLON DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SNARE WOULD NOT COMPLETELY CLOSE AFTER ITS FIRST OPENING. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF THE CAUTERY PIN DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880005 ↗
• MalfunctionJan 9, 2026Break; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIRST SNARE WAS DIFFICULT TO OPEN/CLOSE, THEN HANDLE POPPED AND NOTED A SILVER PIECE IN HANDLE BROKE AND WAS UNABLE TO CLOSE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. BASED ON THE INVESTIGATION RESULT OF THE CAUTERY PIN WAS LOOSENED; THIS IS NOW A REPORTABLE EVENT. PLEASE SEE BLOCK H11 FOR INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023222 ↗
• MalfunctionNov 19, 2025Retraction Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Retraction Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW WAS USED DURING ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DURING THE PROCEDURE, AS THE SNARE ENTERED THE ENDOSCOPE AND REACHED THE POLYP POSITION, THE SNARE OPENED. IT REACHED TO THE POLYP VIA ENDOSCOPE; THE POLYP WAS CAPTURED BUT COULD NOT BE CUT OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SHORT THROW. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594888 ↗
• InjuryJul 30, 2025Failure to Deliver Energy; Entrapment of Device; Failure to Deliver Energy; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW SNARE WAS USED IN THE CECUM DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE AND INSIDE THE PATIENT, A 3 CM PEDUNCULATED POLYP WAS FOUND AT 40 CM. INITIAL ATTEMPTS TO REMOVE IT USING A COLD SNARE WITH ENERGY WERE UNSUCCESSFUL DUE TO A LACK OF ENERGY TRANSMISSION. DESPITE CHANGING THE BOVIE PAD AND ACTIVE CORD AND ENSURING THE SNARE WAS SECURELY CONNECTED WITHOUT ISSUES AT THE CAUTERY PIN, COAGULATION STILL FAILED. THE SNARE BECAME STUCK AND COULD NOT BE REMOVED WITHOUT RISKING INJURY. AS A RESULT, THE HANDLE WAS CUT, AND THE WIRE WAS TAPED TO THE PATIENT'S THIGH. THE PATIENT WAS SENT TO SURGERY THE SAME DAY FOR DEVICE REMOVAL. POST-PROCEDURE TESTING CONFIRMED THAT THE ERBE GENERATOR WAS FUNCTIONING PROPERLY, AS IT WORKED WITH A HOT BIOPSY FORCEPS AND WAS SUCCESSFULLY USED IN A SUBSEQUENT ERCP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665659 ↗
• MalfunctionApr 3, 2025Electrical /Electronic Property Problem; Device-Device Incompatibility; Electrical /Electronic Property Problem; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE FOR POLYPECTOMY PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE HANDPIECE THAT THE TECHNICIAN WAS HOLDING, TO WHICH THE CAUTERY CORD WAS ATTACHED, WAS GETTING VERY HOT. IT APPEARED THAT THE CAUTERY ELECTRODES WERE NOT FUNCTIONING AS THEY SHOULD. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SMALL OVAL FLEXIBLE SNARE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON APRIL 15, 2025: THE ANATOMY LOCATION IS IN THE LEFT LATERAL COLON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769861 ↗
• MalfunctionJan 8, 2025Electrical /Electronic Property Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Electrical /Electronic Property Problem; Detachment of Device or Device Component; Device-Device Incompatibility

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE SENSATION SHORT THROW SNARES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW SNARE WAS USED IN THE STOMACH DURING A POLYPECTOMY PROCEDURE FOR POLYPS PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS NO ENERGY FROM THE ERBE MACHINE AS THE DOCTOR STEPPED ON THE PEDAL. THE PHYSICIAN TRIED SEVERAL TIMES AND WAS UNABLE TO COMMENCE POLYPECTOMY. THE PHYSICIAN TRIED TO REPOSITION SNARE, BUT THE RESULTS ARE SIMILAR. TWO OTHER DEVICES WERE USED WITH THE SAME RESULT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SENSATION SHORT THROW SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105162 ↗
• MalfunctionFeb 26, 2024Electrical /Electronic Property Problem; Entrapment of Device; Failure to Cut; Electrical /Electronic Property Problem; Entrapment of Device; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW SNARE WAS USED TO REMOVE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE DID NOT CUT A LARGE 2CM PEDUNCULATED POLYP. THE NURSE REPORTED THAT THE CAUTERY WAS WORKING BUT IT DID NOT SHOW THAT IT WAS CUTTING THROUGH ON THE SCREEN. IT SHOWED NO CHANGE IN COLOR OF TISSUE AND THE NURSE SAID THAT IT DIDN'T BUBBLE UP. THE CAUTERY MACHINES AND PEDALS WERE SWITCHED BUT STILL IT WAS UNSUCCESSFUL. THE SNARE LOOP WAS EMBEDDED IN THE TISSUE, AND AFTER 10-15 MINUTES OF ATTEMPTING TO REMOVE THE SNARE FROM THE LONG POLYP WITHOUT SUCCESS, THE SNARE WAS REPOSITIONED AND CAUTERY WAS ATTEMPTED AGAIN AND THE SNARE WAS ABLE TO CUT THROUGH THE POLYP SUCCESSFULLY. 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 18784358 ↗
• MalfunctionAug 8, 2023Use of Device Problem; Detachment of Device or Device Component; Difficult to Advance; Use of Device Problem; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT BECAME LODGED IN THE WORKING CHANNEL, CAUSING THE LOOP OF THE SNARE TO BREAK AWAY FROM THE WIRE. THE PROCEDURE WAS COMPLETED WITH AN EXALT SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484611 ↗
• MalfunctionMay 15, 2023Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, A SNARE WAS USED TO RESECT THE POLYP HOWEVER THE HANDLE CANNULA GOT BENT WHEN THE TECHNICIAN PULLED DOWN THE HANDLE TO RESECT THE POLYP. THE ACCOUNT WITHDREW THE DEFECTIVE SNARE FROM THE SCOPE AND OPENED A SECOND SNARE WHICH WORKED SUFFICIENTLY. IT WAS NOT REPORTED WHAT KIND OF SNARE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935387 ↗
• MalfunctionFeb 22, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE THE SNARE DID NOT COAGULATE, AND THE PROCEDURE TIME WAS EXTENDED DUE TO INCREASED BLEEDING OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SENSATION SNARE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16418358 ↗
• MalfunctionNov 18, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN WAS ABOUT TO RESECT THE POLYP WHEN A CLICK SOUND WAS NOTED AND THE POLYP WAS RESECTED PREMATURELY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825326 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE GOT UNRAVELED SHOWING A PIECE OF METAL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322188 ↗
• MalfunctionAug 5, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE WIRE UNRAVELED. 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 15174243 ↗
• MalfunctionAug 4, 2022Unraveled Material

  POLYPECTOMY SNARE BECAME UNRAVELED SHOWING A PIECE OF METAL DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15163214 ↗
• MalfunctionJun 6, 2022Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED FOR ROUTINE COLONOSCOPY SCREENING IN THE TRANSVERSE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO REMOVE A 1.5CM POLYP IN THE TRANSVERSE COLON. THE SNARE WASN'T ABLE TO CUT THROUGH THE MUCOSA. THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD WITH NO VISIBLE ISSUE NOTED WITH THE CAUTERY PIN. THERE WERE NO SIGN OF BLANCHING. THEY USED AN ERBE AUTO CUT GENERATOR. 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 14605981 ↗
• MalfunctionDec 1, 2021Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED TO REMOVE POLYPS IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE DID NOT CUT PROPERLY. THE SNARE WAS UNABLE TO DELIVER ENERGY, HOWEVER, THE SNARE WAS SECURELY ATTACHED TO THE ACTIVE CORD WITH AN OLYMPUS GENERATOR AND POWER SETTINGS. NO VISIBLE PROBLEMS WERE NOTED WITH THE CAUTERY PIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909489 ↗
• MalfunctionJun 15, 2021Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SNARE LOOP HAD EXTENSION ISSUES AND THE DEVICE DID NOT PUNCTURE OR CUT THE TARGET POLYP. THERE WERE NO OTHER ISSUES NOTED WITH THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION 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 OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12003438 ↗
• InjuryNov 20, 2020Break; Entrapment of Device; Retraction Problem; Break; Entrapment of Device; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SHORT THROW WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020 ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE HANDLE MECHANISM BROKE AND THE SNARE FAILED TO CLOSE PROPERLY DURING THE POLYPECTOMY. REPORTEDLY, THE SNARE LOOP BECAME STUCK IN THE POLYP AND THE TECH WAS FORCED TO CUT THE SNARE WIRE BY THE HANDLE IN ORDER TO FORCE PULL THE LOOP INTO THE CATHETER. THE SNARE WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875620 ↗
• MalfunctionOct 29, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH PLASTIC STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, AS THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE STENT IT BECAME VERY DIFFICULT TO REMOVE, AND THE SNARE LOOP BROKE. REPORTEDLY, THERE WERE NO TROUBLESHOOTING STEPS PERFORMED. ALTHOUGH THE PROCEDURE WAS COMPLETED, IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. 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 10756638 ↗
• MalfunctionAug 17, 2020Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION SMALL OVAL FLEXIBLE SNARE WAS USED INSIDE THE COLON DURING A COLONSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE WOULD NOT CUT THROUGH A PEDUNCULATED POLYP. THEY INITIALLY THOUGHT THAT THERE WAS A BAD CONNECTION WITH THE CABLE AND THAT'S WHY IT WAS NOT CUTTING. THEN THEY GOT A NEW CABLE AND STILL, IT WOULD NOT CUT THROUGH THE TARGET POLYP. THEY SWITCHED TO A NEW SNARE AND IT WORKED FINE. REPORTEDLY, NO VISIBLE ISSUE WAS NOTED WITH THE CAUTERY PINS. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417337 ↗