EndoVive Safety PEG Kit M00509000Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729880387), received between May 10, 2022 and Sep 18, 2026 — classified as 5 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. Feb 10, 2026Class IIOpen, Classified

   Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.

   Z-1551-2026 · Root cause: Process control · 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.

• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828056 ↗
• MalfunctionAug 25, 2026Break

  It was reported to Boston Scientific Corporation that an EndoVive Safety PEG Kit Pull Method was used in the upper GI tract during an Esophagogastroduodenoscopy (EGD) with placement of a PEG procedure to treat cancer performed on (b)(6) 2026.During the procedure, there was a Pull PEG being place on a patient as they were passing the peg portion and pulling it through the patient, the metal cable snapped/sheered. Luckly there was small portion of the bed that came out of the opening in the stomach that allowed the doctor to fully pull it through. The procedure was completed with the same original 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 50423134 ↗
• InjuryMay 21, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THEY WERE PULLING THE PEG TUBE THROUGH THE INCISION, THE WIRE SNAPPED. THERE WAS ENOUGH LEFT OVER THAT THE PHYSICIAN WAS ABLE TO GRAB THE WIRE THAT WAS CONNECTED TO THE TIP OF THE PEG WITH A PAIR OF HEMOSTATS AND GUIDE THE TUBE THE REST OF THE WAY THROUGH THE INCISION. IT WAS REPORTED THAT THEY COMPLETED MOST OF THE PROCEDURE WHEN THE PROBLEM OCCURRED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS EXPECTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243949 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE PHYSICIAN USED THE SNARE TO PULL THE WIRE THROUGH THE ESOPHAGUS OF THE PATIENT, IT WAS REPORTED THAT THE WIRE SEPARATED (BROKE) AWAY FROM SNARE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL ENDOVIVE SAFETY PEG USING AN ALTERNATE DEVICE TO PULL AND PLACE THE PEG TUBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049666 ↗
• InjuryMar 25, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE NURSE COMPLETED THE CUT SITE, THE PHYSICIAN ADVANCED THE WIRE AND PASSED THE PULL WIRE THROUGH THE PEG TUBE AS USUAL. THE PEG WAS THEN PULLED DOWN THROUGH THE ESOPHAGUS AND INTO THE STOMACH. WHEN ATTEMPTING TO PULL THE PEG THROUGH THE GASTRIC WALL AND INTO THE STOMACH, THE LOOPED PULL WIRE AT THE TIP OF THE PEG BROKE. USING HEMOSTATS, THE TEAM WAS ABLE TO GRASP THE BROKEN PULL WIRE AT THE TIP OF THE PEG AND SUCCESSFULLY COMPLETE PLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694408 ↗
• MalfunctionMar 10, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS UNPACKED ON FEBRUARY 09, 2026. IT WAS REPORTED THAT THERE WAS A PIECE OF HAIR INSIDE THE PACKAGING. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWS A HAIR-LIKE PARTICLE ON THE DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559713 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING A PEG TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE PULLING THE WIRE THROUGH THE BOLSTER, THE WIRE EXITED THE STOMACH AND SUBSEQUENTLY SNAPPED. THE CLINICAL TEAM WAS ABLE TO RETRIEVE THE WIRE AND COMPLETE THE DEPLOYMENT USING 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 23884493 ↗
• MalfunctionDec 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS UNPACKED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, A HAIR WAS SEEN IN THE PACKAGE NEAR SNARE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823483 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE GASTRIC DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE TRANSFERRING THE PEG TUB FROM INSIDE THE STOMACH OUTSIDE OF THE STOMA SITE. THE NITINOL WIRE THAT IS ATTACHED TO THE PEG TUB, SNAPPED. THUS, NOT ALLOWING ENOUGH ROOM TO PULL THE TUB OUT AND HAVING TO REMOVE THE TUB FROM THE PATIENT. 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 23697560 ↗
• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN PULLING THE PEG TUBE INTO POSITION, THE WIRE THAT IS USED TO PULL THE PEG TUBE BROKE. IT WAS REPORTED THAT NO PART OF THE WIRE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786343 ↗
• MalfunctionJun 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PEG PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, WHEN THE DEVICE WAS INSERTED THE HEALTHCARE PROFESSIONAL NOTICED A HOLE ON THE DEVICE TUBING. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME ENDOVIVE SAFETY PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324075 ↗
• InjuryOct 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE PHYSICIAN WENT TO PULL THE PEG TUBE THROUGH THE STOMACH OF THE PATIENT THE INTERNAL BOLSTER FELL OFF AND HAD TO BE RETRIEVED WITH A RESCUE NET. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362041 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024 . DURING THE PROCEDURE, THE PHYSICIAN WAS PULLING THE PEG TUBE THROUGH THE PATIENT'S ABDOMEN AND THE PULL WIRE BROKE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302506 ↗
• MalfunctionSep 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. POST PROCEDURE, THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS DISLODGED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272824 ↗
• MalfunctionSep 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED IN A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. POST PROCEDURE, THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS DISLODGED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272794 ↗
• MalfunctionSep 17, 2024Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENDOVIVE SAFETY PEG KIT PULL METHODS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED IN THE GASTROINTESTINAL (GI) TRACT AND STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE LOOP WIRE BROKE ON THE PEG KIT WHILE IT WAS INSIDE THE PATIENT. ANOTHER PEG KIT WAS DEPLOYED, AND THE WIRE ALSO BROKE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237382 ↗
• MalfunctionSep 17, 2024Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENDOVIVE SAFETY PEG KIT PULL METHODS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED IN THE GASTROINTESTINAL (GI) TRACT AND STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE LOOP WIRE BROKE ON THE PEG KIT WHILE IT WAS INSIDE THE PATIENT. ANOTHER PEG KIT WAS DEPLOYED, AND THE WIRE ALSO BROKE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237147 ↗
• MalfunctionAug 26, 2024Break; Break

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE INSERTION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, LOOP/SNARE WIRE SNAPPED AND COULD NOT BE USED. A SECOND ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED BUT THE LOOP/SNARE WIRE SNAPPED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND WAS RESCHEDULED AS NO ADDITIONAL PEG KITS WERE AVAILABLE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072268 ↗
• MalfunctionAug 26, 2024Break; Break

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE INSERTION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, LOOP/SNARE WIRE SNAPPED AND COULD NOT BE USED. A SECOND ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED BUT THE LOOP/SNARE WIRE SNAPPED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND WAS RESCHEDULED AS NO ADDITIONAL PEG KITS WERE AVAILABLE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072178 ↗
• InjurySep 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE PEG TUBE DISLODGED. THE PATIENT REMAINED IN THE HOSPITAL. REPORTEDLY, ON (B)(6) 2023, PATIENT HAD A T-TAG ADDED TO THE DEVICE AND WAS RELEASED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808984 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT WITH MONITORED ANESTHESIA PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT WHEN ATTEMPTING TO PULL THE TROCAR THROUGH, THE WIRE BROKE. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 17776261 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT WITH MONITORED ANESTHESIA PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT WHEN ATTEMPTING TO PULL THE TROCAR THROUGH, THE WIRE BROKE. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 17773752 ↗
• MalfunctionSep 19, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT WITH MONITORED ANESTHESIA PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT WHEN ATTEMPTING TO PULL THE TROCAR THROUGH, THE WIRE PARTIALLY BROKE. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 17772752 ↗
• InjurySep 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT, DURING DEVICE PLACEMENT, THE INTERNAL BOLSTER DETACHED WHEN BEING PULLED THROUGH. THE DETACHED PORTION WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG KIT PULL METHOD. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17767673 ↗
• MalfunctionSep 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT, DURING DEVICE PLACEMENT, THE INTERNAL BOLSTER DETACHED WHEN BEING PULLED THROUGH. 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 17764398 ↗