EndoVive Safety PEG Kit M00566490Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729748410), received between Feb 27, 2017 and May 26, 2022 — classified as 2 deaths, 5 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE (B)(6) 2022. DURING THE PROCEDURE, THE PEG TUBE DETACHED AT THE TRANSITION ZONE JUNCTION. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14503239 ↗
• InjuryMar 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, WHEN PEG TUBE WAS BEING DEPLOYED OVER A GUIDEWIRE, IT SEPARATED INTO TWO PIECES. IT WAS REPORTED THAT A GASTROSCOPE WAS UTILIZED TO RETRIEVED THE DETACHED PORTION. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE 20FR PEG TUBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776488 ↗
• MalfunctionFeb 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE PEG TUBE DETACHED AS IT WAS PULLED THROUGH THE STOMA. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538631 ↗
• MalfunctionFeb 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, WHEN CUTTING THE TUBE IT SPLIT AND SEPARATED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13533946 ↗
• MalfunctionFeb 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE PEG TUBE DETACHED AT TRANSITION ZONE WHILE PHYSICIAN PULLED IT THROUGH THE STOMA SITE. IT WAS REPORTED THAT THE DETACHED PORTION WAS PULLED OUT BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497108 ↗
• MalfunctionMay 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2020. DURING THE PROCEDURE, WHEN PEG TUBE WAS PLACED, IT SEPARATED AT THE TRANSITION CONNECTOR. A KELLY CLAMP WAS USED TO GRAB THE TUBE TO MAINTAIN TRACTION TO ACHIEVE PROPER TUBE PLACEMENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770765 ↗
• DeathDec 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2020-06245 FOR THE FIRST ENDOVIVE SAFETY PEG PUSH METHOD AND MANUFACTURER REPORT# 3005099803-2020-06244 FOR THE SECOND ENDOVIVE SAFETY PEG PUSH METHOD. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG PUSH METHOD WAS PLACED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THEY WERE PULLING THE PEG TUBE THROUGH THE STOMA, THE PEG TUBE DETACHED. THE DETACHED PEG TUBE WAS RETRIEVED USING A SNARE. A SECOND ENDOVIVE SAFETY PEG PUSH METHOD WAS OPENED AND USED; HOWEVER, THE SAME THING HAPPENED. AFTER THE SECOND ATTEMPTED PLACEMENT OF THE PEG TUBE THE STOMACH COULD NO LONGER BE INSUFFLATE. IT WAS NOTED THAT THE AIR WAS ESCAPING INTO THE CAVITY (STOMACH WALL). THE PROCEDURE WAS STOPPED BECAUSE THE PHYSICIAN COULD NO LONGER INSUFFLATE. IN LIEU OF THE PEG TUBE, A NASOGASTRIC (NG) TUBE WAS INSERTED INTO THE PATIENT. REPORTEDLY, THE PATIENT DEVELOPED PNEUMOPERITONITIS. IT COULD NOT BE CONFIRMED IF THE PNEUMOPERITONITIS WAS TREATED. ON (B)(6) 2020

  Patient problems: Death; Peritonitis

  MAUDE report 11049926 ↗
• DeathDec 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2020-06245 FOR THE FIRST ENDOVIVE SAFETY PEG PUSH METHOD AND MANUFACTURER REPORT# 3005099803-2020-06244 FOR THE SECOND ENDOVIVE SAFETY PEG PUSH METHOD. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG PUSH METHOD WAS PLACED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THEY WERE PULLING THE PEG TUBE THROUGH THE STOMA, THE PEG TUBE DETACHED. THE DETACHED PEG TUBE WAS RETRIEVED USING A SNARE. A SECOND ENDOVIVE SAFETY PEG PUSH METHOD WAS OPENED AND USED; HOWEVER, THE SAME THING HAPPENED. AFTER THE SECOND ATTEMPTED PLACEMENT OF THE PEG TUBE THE STOMACH COULD NO LONGER BE INSUFFLATE. IT WAS NOTED THAT THE AIR WAS ESCAPING INTO THE CAVITY (STOMACH WALL). THE PROCEDURE WAS STOPPED BECAUSE THE PHYSICIAN COULD NO LONGER INSUFFLATE. IN LIEU OF THE PEG TUBE, A NASOGASTRIC (NG) TUBE WAS INSERTED INTO THE PATIENT. REPORTEDLY, THE PATIENT DEVELOPED PNEUMOPERITONITIS. IT COULD NOT BE CONFIRMED IF THE PNEUMOPERITONITIS WAS TREATED. ON (B)(6) 2020

  Patient problems: Death; Peritonitis

  MAUDE report 11049616 ↗
• MalfunctionFeb 25, 2020Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS INSPECTED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, UPON INSPECTION OF INVENTORY A BULGE WAS FOUND IN THE PEG TUBE. THE EXACT LOCATION IS UNKNOWN, HOWEVER IT WAS BETWEEN THE DILATOR TIP PORTION AND THE BOLSTER. REPORTEDLY, THIS DEVICE WAS NOT USED IN A PATIENT OR PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9751719 ↗
• MalfunctionFeb 25, 2020Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS INSPECTED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, UPON INSPECTION OF INVENTORY A BULGE WAS FOUND IN THE PEG TUBE. THE EXACT LOCATION IS UNKNOWN, HOWEVER IT WAS BETWEEN THE DILATOR TIP PORTION AND THE BOLSTER. REPORTEDLY, THIS DEVICE WAS NOT USED IN A PATIENT OR PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9751715 ↗
• MalfunctionFeb 25, 2020Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO PLACE THE PEG TUBE, A BULGE WAS FOUND. THE EXACT LOCATION IS UNKNOWN, HOWEVER IT WAS BETWEEN THE DILATOR TIP PORTION AND THE BOLSTER. REPORTEDLY DUE TO THIS IT WOULD BE DIFFICULT TO PLACE THE PEG TUBE IN THE PATIENT THEREFORE THIS DEVICE WAS NOT USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9751566 ↗
• InjuryJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS PULLING THE PEG TUBE, IT DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC. REPORTEDLY, A DIFFERENT TOOL/DEVICE (UNKNOWN DEVICE) WAS USED TO PULL THE DETACHED PORTION. THE PROCEDURE WAS COMPLETED WITH THIS 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557267 ↗
• MalfunctionDec 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE PEG TUBE WAS PULLED THROUGH THE GASTRIC WALL, IT SEPARATED AND BROKE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9436846 ↗
• MalfunctionDec 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE PEG TUBE WAS PULLED THROUGH THE GASTRIC WALL, IT SEPARATED AND BROKE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9436826 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) REPLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PEG TUBE DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC WHEN THE PHYSICIAN PULLED IT OUT FROM THE PATIENT. REPORTEDLY, THERE WAS NOTHING LEFT INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459580 ↗
• MalfunctionJan 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2019.   ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PEG TUBE DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC WHEN IT WAS INSERTED INTO THE ABDOMEN. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD.   THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281968 ↗
• MalfunctionJan 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PHYSICIAN PULLED THE PEG TUBE FROM THE ABDOMEN, IT SNAPPED INTO HALF. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD.   THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248696 ↗
• MalfunctionNov 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE SAFETY PEG KIT PUSH METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FEEDING TUBE DETACHED AS THE PHYSICIAN WAS TRYING TO PULL IT THROUGH THE INCISION SITE. A SECOND SAFETY PEG KIT PUSH METHOD; HOWEVER, SAME THING HAPPENED, THE FEEDING TUBE DETACHED UPON PULLING IT THROUGH THE INCISION SITE. THE PROCEDURE WAS STILL COMPLETED WITH THE SECOND ENDOVIVE SAFETY PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112650 ↗
• MalfunctionNov 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ENDOVIVE SAFETY PEG KIT PUSH METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FEEDING TUBE DETACHED AS THE PHYSICIAN WAS TRYING TO PULL IT THROUGH THE INCISION SITE. A SECOND SAFETY PEG KIT PUSH METHOD; HOWEVER, SAME THING HAPPENED, THE FEEDING TUBE DETACHED UPON PULLING IT THROUGH THE INCISION SITE. THE PROCEDURE WAS STILL COMPLETED WITH THE SECOND ENDOVIVE SAFETY PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112566 ↗
• MalfunctionApr 25, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE IN (B)(6) 2018, WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE PEG TUBE, THE PEG TUBE DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. 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 7460782 ↗
• InjuryApr 9, 2018Detachment Of Device Component; Detachment Of Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-01138 FOR THE FIRST ENDOVIVE¿ SAFETY PEG PUSH KIT AND 3005099803-2018-01139 FOR THE SECOND ENDOVIVE¿ SAFETY PEG PUSH KIT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ENDOVIVE¿ SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS TRACKING THE PEG TUBE OVER THE GUIDEWIRE, THE PEG TUBE DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC INSIDE THE PATIENT. A SECOND ENDOVIVE¿ SAFETY PEG KIT PUSH METHOD WAS USED; HOWEVER, THE PEG TUBE ALSO DETACHED. THE DETACHED PORTION WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7406908 ↗
• InjuryApr 9, 2018Detachment Of Device Component; Detachment Of Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO THIS MANUFACTURER REPORT FOR THE FIRST ENDOVIVE¿ SAFETY PEG PUSH KIT AND 3005099803-2018-01139 FOR THE SECOND ENDOVIVE¿ SAFETY PEG PUSH KIT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ENDOVIVE¿ SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS TRACKING THE PEG TUBE OVER THE GUIDEWIRE, THE PEG TUBE DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC INSIDE THE PATIENT. A SECOND ENDOVIVE¿ SAFETY PEG KIT PUSH METHOD WAS USED; HOWEVER, THE PEG TUBE ALSO DETACHED. THE DETACHED PORTION WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7406907 ↗
• MalfunctionApr 5, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS PLACING THE PEG TUBE, IT DETACHED INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DETACHED PEG TUBE (UNKNOWN WHAT METHOD WAS USED.) THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399019 ↗
• MalfunctionMar 30, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN PULLED THE PEG TUBE FOR REPLACEMENT, THE PEG TUBE DETACHED AT THE TRANSITION ZONE BETWEEN THE HARD AND SOFT PLASTIC. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7386173 ↗
• MalfunctionMar 30, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, WHEN THE PEG TUBE WAS PULLED THROUGH THE SKIN, THE INTERNAL BOLSTER DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE SAFETY PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO 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 7384956 ↗