Interject M00518250Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 08714729415091), received between Aug 2, 2017 and May 27, 2025 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (69 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 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 AN INTERJECT NEEDLE WAS USED IN THE POLYPS DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SHEATH. ANOTHER INTERJECT NEEDLE 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 22088046 ↗
• MalfunctionJun 26, 2018Occlusion Within Device; Occlusion Within Device

  AN INTERJECT NEEDLE WAS RECEIVED FOR ANALYSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS HAS BEEN MADE A REPORTABLE EVENT DUE TO INVESTIGATION RESULTS OF NEEDLE -BLOCKED/OCCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640160 ↗
• MalfunctionJun 26, 2018Occlusion Within Device; Occlusion Within Device

  AN INTERJECT NEEDLE WAS RECEIVED FOR ANALYSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS HAS BEEN MADE A REPORTABLE EVENT DUE TO INVESTIGATION RESULTS OF NEEDLE -BLOCKED/OCCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640144 ↗
• MalfunctionJun 26, 2018Occlusion Within Device; Occlusion Within Device

  AN INTERJECT NEEDLE WAS RECEIVED FOR ANALYSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS HAS BEEN MADE A REPORTABLE EVENT DUE TO INVESTIGATION RESULTS OF NEEDLE -BLOCKED/OCCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640136 ↗
• MalfunctionJun 26, 2018Occlusion Within Device; Occlusion Within Device

  AN INTERJECT NEEDLE WAS RECEIVED FOR ANALYSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS HAS BEEN MADE A REPORTABLE EVENT DUE TO INVESTIGATION RESULTS OF NEEDLE -BLOCKED/OCCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640107 ↗
• MalfunctionJun 26, 2018Occlusion Within Device; Occlusion Within Device

  AN INTERJECT NEEDLE WAS RECEIVED FOR ANALYSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS HAS BEEN MADE A REPORTABLE EVENT DUE TO INVESTIGATION RESULTS OF NEEDLE -BLOCKED/OCCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640044 ↗
• MalfunctionJun 22, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE WAS UNABLE TO FLUSH THE SODIUM CHLORIDE THROUGH THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 7628809 ↗
• MalfunctionJun 22, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CHANNEL WAS BLOCKED AND NO ADRENALINE COULD BE PUSHED THROUGH. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 7628782 ↗
• MalfunctionJun 18, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING AN INJECTION PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE NEEDLE WAS OCCLUDED. REPORTEDLY THE SUBSTANCE THEY WERE TRYING TO INJECT WAS SODIUM CHLORIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ SCLEROTHERAPY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7609510 ↗
• MalfunctionJun 18, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A INTERJECT SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING AN INJECTION PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS IMPOSSIBLE TO INJECT ANY LIQUID. REPORTEDLY THE SUBSTANCE THEY WERE TRYING TO INJECT WAS SODIUM CHLORIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT SCLEROTHERAPY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7609507 ↗
• MalfunctionJun 15, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE NEEDLE WAS UNABLE TO FLUSH THE LIQUID OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ SCLEROTHERAPY NEEDLE. 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 7608009 ↗
• MalfunctionJun 15, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS IMPOSSIBLE TO INJECT ANY FLUID. REPORTEDLY THE SUBSTANCE THEY WERE TRYING TO INJECT WAS SODIUM CHLORIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ SCLEROTHERAPY NEEDLE. 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 7607979 ↗
• MalfunctionJun 11, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, AT THE TIME OF THE INJECTION, THE LIQUID DID NOT LEAVE THE NEEDLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7588189 ↗
• MalfunctionJun 7, 2018Occlusion Within Device; Occlusion Within Device

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01827 FOR THE FIRST INTERJECT¿ SCLEROTHERAPY NEEDLE AND 3005099803-2018-01828 FOR THE SECOND INTERJECT¿ SCLEROTHERAPY NEEDLE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE STOMACH DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, AT THE TIME OF INJECTION THE LIQUID DID NOT LEAVE THE NEEDLE. A SECOND INTERJECT ¿ NEEDLE WAS USED, AND HAD THE SAME ISSUE OF LIQUID NOT LEAVING THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 Consequences Or Impact To Patient

  MAUDE report 7578758 ↗
• MalfunctionJun 7, 2018Occlusion Within Device; Occlusion Within Device

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01827 FOR THE FIRST INTERJECT¿ SCLEROTHERAPY NEEDLE AND 3005099803-2018-01828 FOR THE SECOND INTERJECT¿ SCLEROTHERAPY NEEDLE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE STOMACH DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, AT THE TIME OF INJECTION THE LIQUID DID NOT LEAVE THE NEEDLE. A SECOND INTERJECT ¿ NEEDLE WAS USED, AND HAD THE SAME ISSUE OF LIQUID NOT LEAVING THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 Consequences Or Impact To Patient

  MAUDE report 7578740 ↗
• MalfunctionJun 6, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE STOMACH DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN TRYING TO INJECT, THE LIQUID DID NOT LEAVE THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 Consequences Or Impact To Patient

  MAUDE report 7575939 ↗
• MalfunctionJun 1, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS IMPOSSIBLE TO INJECT THROUGH THE NEEDLE. IT WAS REPORTED TO BE COMPLETELY BLOCKED. IT WAS REPORTED THAT EVEN WATER COULD NOT BE FLUSHED THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 "OKAY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7563329 ↗
• MalfunctionJun 1, 2018Occlusion Within Device; Occlusion Within Device

  NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01696 FOR THE FIRST INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01697 FOR THE SECOND INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01698 FOR THE THIRD INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01699 FOR THE FOURTH INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01700 FOR THE FIFTH INTERJECT¿ SCLEROTHERAPY NEEDLE AND 3005099803-2018-01701 FOR THE SIXTH INTERJECT¿ SCLEROTHERAPY NEEDLE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS IMPOSSIBLE TO INJECT THE PRODUCT INTO THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 7563167 ↗
• MalfunctionJun 1, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS IMPOSSIBLE TO INJECT THE PRODUCT INTO THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 7563160 ↗
• MalfunctionJun 1, 2018Occlusion Within Device; Occlusion Within Device

  NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01696 FOR THE FIRST INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01697 FOR THE SECOND INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01698 FOR THE THIRD INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01699 FOR THE FOURTH INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01700 FOR THE FIFTH INTERJECT¿ SCLEROTHERAPY NEEDLE AND 3005099803-2018-01701 FOR THE SIXTH INTERJECT¿ SCLEROTHERAPY NEEDLE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS IMPOSSIBLE TO INJECT THE PRODUCT INTO THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 7563153 ↗
• MalfunctionJun 1, 2018Occlusion Within Device; Occlusion Within Device

  THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01696 FOR THE FIRST INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01697 FOR THE SECOND INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01698 FOR THE THIRD INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01699 FOR THE FOURTH INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01700 FOR THE FIFTH INTERJECT¿ SCLEROTHERAPY NEEDLE AND 3005099803-2018-01701 FOR THE SIXTH INTERJECT¿ SCLEROTHERAPY NEEDLE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS IMPOSSIBLE TO INJECT THE PRODUCT INTO THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 7563117 ↗
• MalfunctionJun 1, 2018Occlusion Within Device; Occlusion Within Device

  NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01696 FOR THE FIRST INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01697 FOR THE SECOND INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01698 FOR THE THIRD INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01699 FOR THE FOURTH INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01700 FOR THE FIFTH INTERJECT¿ SCLEROTHERAPY NEEDLE AND 3005099803-2018-01701 FOR THE SIXTH INTERJECT¿ SCLEROTHERAPY NEEDLE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS IMPOSSIBLE TO INJECT THE PRODUCT INTO THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 7563068 ↗
• MalfunctionJun 1, 2018Occlusion Within Device; Occlusion Within Device

  NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01696 FOR THE FIRST INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01697 FOR THE SECOND INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01698 FOR THE THIRD INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01699 FOR THE FOURTH INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01700 FOR THE FIFTH INTERJECT¿ SCLEROTHERAPY NEEDLE AND 3005099803-2018-01701 FOR THE SIXTH INTERJECT¿ SCLEROTHERAPY NEEDLE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS IMPOSSIBLE TO INJECT THE PRODUCT INTO THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 7563000 ↗
• MalfunctionJun 1, 2018Occlusion Within Device; Occlusion Within Device

  NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01696 FOR THE FIRST INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01697 FOR THE SECOND INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01698 FOR THE THIRD INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01699 FOR THE FOURTH INTERJECT¿ SCLEROTHERAPY NEEDLE, 3005099803-2018-01700 FOR THE FIFTH INTERJECT¿ SCLEROTHERAPY NEEDLE AND 3005099803-2018-01701 FOR THE SIXTH INTERJECT¿ SCLEROTHERAPY NEEDLE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ SCLEROTHERAPY NEEDLE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IT WAS IMPOSSIBLE TO INJECT THE PRODUCT INTO THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT¿ NEEDLE. 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 7562988 ↗
• MalfunctionMay 25, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT¿ NEEDLE WAS TO BE USED IN A POLYP INFILTRATION AND ULCER INJECTION THERAPY PROCEDURE PERFORMED IN THE ESOPHAGUS AND STOMACH. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NEEDLE WAS NOTICED TO BE OCCLUDED. REPORTEDLY THE SUBSTANCE THEY WERE TRYING TO INJECT WAS ADRENALINE. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7545467 ↗