TRUEtome 49 M00584150Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08714729827610), received between Apr 17, 2018 and Sep 29, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937971 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550087 ↗
• MalfunctionMar 18, 2026Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS PREPARED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PREPARATION OUTSIDE THE PATIENT, THE DEVICE WAS UNPACKED AND THE GUIDE WIRE WAS BEING PRE-INSTALLED. IT WAS THEN OBSERVED THAT THE TIP OF THE TOME WAS BENT TO THE RIGHT AND COULD NOT BE ROTATED USING THE HANDLE TO ADJUST TO THE NORMAL INSERTION ANGLE. AS A RESULT, THE CATHETER COULD NOT BE INSERTED SUCCESSFULLY DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634516 ↗
• MalfunctionJan 6, 2026Difficult to Advance; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN TRUETOME 49 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR BILE DUCT DILATATION PERFORMED ON (B)(6) 2025. DURING PREPARATION OUTSIDE THE PATIENT FOR A COMMON BILE DUCT DILATION PROCEDURE, THE TRUETOME 39 SPHINCTEROTOME WAS UNPACKED AND PREPARED FOR GUIDE WIRE PRE-INSTALLATION. UPON INSPECTION, THE TIP OF THE SPHINCTEROTOME WAS FOUND TO BE BENT. DESPITE ATTEMPTS, INTUBATION WAS UNSUCCESSFUL USING THIS DEVICE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED SUCCESSFULLY USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE CUTTING WIRE KINKED. PLEASE REFER TO BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985499 ↗
• MalfunctionDec 2, 2025Break; 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 TRUETOME 49 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE DOING THE DUODENAL PAPILLA INCISION, AS THE DEVICE WAS ELECTRIFIED, THE CUTTING WIRE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 49. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700820 ↗
• MalfunctionDec 2, 2025Break; 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 TRUETOME 49 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STONES PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT WHILE ON THE PROCESS OF DUODENAL PAPILLA INCISION, THE WIRE WAS FRACTURED WHEN THE TOME WAS ELECTRIFIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 49. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699738 ↗
• MalfunctionNov 24, 2025Break; 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 TRUETOME 49 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS FOUND THAT THE CUTTING WIRE FRACTURED WHEN THE DEVICE WAS ENERGIZED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 23634064 ↗
• MalfunctionOct 9, 2025Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED, AND THE TIP OF THE CUTTING WIRE AND THE BOW WERE BENT. 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 23260945 ↗
• MalfunctionOct 8, 2025Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLEDOCHOLITHIASIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN BOWING THE TOME, THE WIRE KINKED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED WHERE IT CAN BE OBSERVED THAT THE CUTTING WIRE WAS KINKED. 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 23251674 ↗
• MalfunctionAug 28, 2025Break; 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 TRUETOME 49 WAS USED IN THE DUODENAL SPHINCTER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE OUTSIDE THE PATIENT, THE CUTTING WIRE OF THE TRUETOME 49 BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 22915531 ↗
• MalfunctionAug 14, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION OUTSIDE THE PATIENT, WHEN THE DEVICE WAS UNPACKED, IT WAS FOUND THAT THE CUTTING WIRE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 22807823 ↗
• MalfunctionJul 21, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 49 WAS USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE FRONT TIP OF THE DEVICE WAS SEVERELY BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 FINDING OF DEVICE CUTTING WIRE KINKED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556330 ↗
• MalfunctionDec 31, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON (B)(6) 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045413 ↗
• MalfunctionDec 31, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON (B)(6) 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045412 ↗
• MalfunctionDec 31, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON (B)(6) 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045397 ↗
• MalfunctionDec 31, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON (B)(6) 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045396 ↗
• MalfunctionDec 31, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON (B)(6) 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045395 ↗
• MalfunctionDec 31, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON DECEMBER 10, 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045384 ↗
• MalfunctionDec 31, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON DECEMBER 10, 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045383 ↗
• MalfunctionDec 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON DECEMBER 10, 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044526 ↗
• MalfunctionDec 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON DECEMBER 10, 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044520 ↗
• MalfunctionDec 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE ON DECEMBER 10, 2024. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTHCARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND A BLUE COLORED FOREIGN MATERIAL CAN BE SEEN INSIDE THE STERILE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044507 ↗
• MalfunctionNov 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE. THE EXACT DATE OF THE EVENT IS UNKNOWN. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTH CARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED AND SHOWED FOREIGN MATERIAL INSIDE THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685331 ↗
• MalfunctionNov 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE. THE EXACT DATE OF THE EVENT IS UNKNOWN. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTH CARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED AND SHOWED FOREIGN MATERIAL INSIDE THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685286 ↗
• MalfunctionNov 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A TRUETOME 49 WAS CHECKED AFTER BEING RECEIVED IN A BSC WAREHOUSE. THE EXACT DATE OF THE EVENT IS UNKNOWN. FOREIGN MATERIAL WAS FOUND INSIDE THE UNOPENED POUCH OF THE DEVICE. IT WAS REPORTED THAT THE STERILE SEAL WAS NOT COMPROMISED, AS ALL PACKAGING SEALS WERE INTACT. THERE WAS NO HEALTH CARE FACILITY, PROCEDURE OR PATIENT INVOLVED IN THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED AND SHOWED FOREIGN MATERIAL INSIDE THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685235 ↗