EndoVive Standard PEG Kit M00568200Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729748687), received between Apr 6, 2017 and Jan 16, 2025 — classified as 8 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED IN A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, BEFORE CLOSING THE INCISION, THEY NOTICED THE WHITE SHEATH COVER OF THE NEEDLE AND THE ORANGE HUB (ALL ONE PIECE USED AS TROCAR) HAD DETACHED AND COME OUT IN THE PERITONEUM OF THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE IT FROM THE PATIENT, BUT IT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHERE THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION RECEIVED JANUARY 29, 2025** IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTERVENTIONAL RADIOLOGY PROCEDURE AND RETURNED TO THE NURSING HOME WITH NO INCISION OR DRESSING TO THE ABDOMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173323 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE PULL WIRE INSIDE THE TUBE BROKE. 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 19283068 ↗
• InjuryFeb 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(4) 2023. IT WAS REPORTED THAT THE PHYSICIANS WERE PLACING A PEG TUBE ENDOSCOPICALLY. AS THEY PULLED THE PEG TUBE THROUGH THE STOMACH AND ABDOMINAL WALL, THE PEG TUBE WENT THROUGH THE INCISION, RESULTING IN AN UNSUCCESSFUL PLACEMENT. A NON-BSC CLIP WAS PLACED ENDOSCOPICALLY TO CLOSE THE STOMA SITE. NO FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793310 ↗
• MalfunctionOct 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, WHILE PULLING THE DEVICE THROUGH THE STOMA SITE THE WHOLE PEG TUBE CAME OUT. 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 18035659 ↗
• MalfunctionMay 25, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT, DURING PEG TUBE PLACEMENT THE BLUE PULLWIRE BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD 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 17003169 ↗
• InjuryMay 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2023. IT WAS REPORTED THAT, DURING DEVICE PLACEMENT, THE PEG TUBE FRACTURED AND LEFT AN OPEN TRACK INTO THE PERITONEAL SPACE. NO PIECES OF THE DEVICE WERE LEFT INSIDE THE PATIENT. THE PATIENT WAS SENT FOR SURGERY. IT WAS REPORTED THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Perforation

  MAUDE report 16938944 ↗
• MalfunctionApr 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. THE INITIAL PLACEMENT WAS SUCCESSFUL. POST PROCEDURE, A FEW DAYS LATER, THE PEG TUBE DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765846 ↗
• MalfunctionApr 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. THE INITIAL PLACEMENT WAS SUCCESSFUL. POST PROCEDURE, A FEW DAYS LATER, THE PEG TUBE DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765845 ↗
• MalfunctionApr 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. THE INITIAL PLACEMENT WAS SUCCESSFUL. POST PROCEDURE, A FEW DAYS LATER, THE PEG TUBE DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765710 ↗
• MalfunctionApr 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE INITIAL PLACEMENT WAS SUCCESSFUL. POST PROCEDURE, A FEW DAYS LATER, THE PEG TUBE DISLODGED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16756007 ↗
• MalfunctionMar 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2022. IT WAS REPORTED POST PROCEDURE, THE PEG TUBE BECAME DISLODGED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD 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 16552025 ↗
• MalfunctionMar 6, 2023Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACEMENT PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, WHILE THE PEG TUBE WAS BEING PULLED, THE TUBE BECAME TORN. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD 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 16490823 ↗
• InjuryFeb 28, 2023Defective Device; Defective Device

  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 PROCEDURE ON (B)(6) 2023. DURING PROCEDURE, THE ANGIOCATH NEEDLE WAS INSERTED, UPON PULLING OUT, PART OF THE SHEATH DETACHED AND DISLODGED INSIDE THE PATIENT. A SURGERY WAS PERFORMED TO RETRIEVE THE DETACHED PORTIONS. THERE WERE REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452088 ↗
• MalfunctionFeb 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY INSERTION PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING TUBE INSERTION, THE PEG TUBE WAS DETACHED AFTER BEING PULLED THROUGH THE STOMA SITE. THE PROCEDURE WAS COMPLETED WITH SAME ORIGINAL ENDOVIVE STANDARD 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 16414302 ↗
• MalfunctionSep 2, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION DURING A STOCK CHECK IN THE SUPPLY ROOM IT WAS NOTED THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD HAD A LIDOCAINE LEAK. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: PACKAGING CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15350507 ↗
• MalfunctionJun 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE DILATOR WAS GENTLY PULLED THROUGH THE SKIN, IT DETACHED LEAVING THE PEG TUBE IN THE STOMACH. IT WAS ABLE TO BE RETRIEVED AND THE PROCEDURE WAS REPEATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645471 ↗
• MalfunctionMay 26, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING PREPARATION, UPON OPENING THE PACKAGING, THE SCISSORS LOOKED RUSTED OR LIKE THEY HAD A FOREIGN MATERIAL ON THEM. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD 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 14513628 ↗
• InjuryOct 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE LOOP END OF THE INITIAL PEG TUBE DETACHED AND BECAME LODGED INSIDE THE WALL OF THE STOMACH. THE PHYSICIAN PULLED ON THE LOOP AND IT CAME OUT HOWEVER, THE STOMA SITE HOLE BECAME BIGGER. THEREFORE THE ORIGINAL PROCEDURE WAS CANCELLED. THE SAME DAY THE PATIENT WAS SENT TO OR TO HAVE THE HOLE REPAIRED. IT WAS REPORTED THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 12672354 ↗
• MalfunctionJul 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS REPORT PERTAINS TO TWO ENDOVIVE STANDARD PEG KITS PULL METHOD. REFER TO MANUFACTURER REPORT# (B)(4) AND 3005099803-2021-03308 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. DURING PROCEDURE, THE PHYSICIAN MADE AN INCISION, PLACED A TROCAR AND THE NEEDLE OF THE TROCAR WAS REMOVED TO FEED THE BLUE INSERTION WIRE. ONCE THE NEEDLE WAS REMOVED, THE TROCAR CATHETER RETRACTED IN THE ABDOMINAL WALL, HOWEVER, THE PHYSICIAN WAS NO LONGER ABLE TO VISUALIZE THE TROCAR CATHETER. A SECOND ENDOVIVE STANDARD PEG KIT PULL METHOD WAS OBTAINED AND THE SAME EVENT OCCURED. THE TROCAR RETRACTED AGAIN AFTER THE NEEDLE WAS REMOVED. THE PROCEDURE WAS STOPPED. THE PATIENT WAS TAKEN TO RECOVERY AND THERE WERE NO UNTOWARD PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131541 ↗
• MalfunctionJul 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO TWO ENDOVIVE STANDARD PEG KITS PULL METHOD. REFER TO MANUFACTURER REPORT# 3005099803-2021-03306 AND 3005099803-2021-03308 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. DURING PROCEDURE, THE PHYSICIAN MADE AN INCISION, PLACED A TROCAR AND THE NEEDLE OF THE TROCAR WAS REMOVED TO FEED THE BLUE INSERTION WIRE. ONCE THE NEEDLE WAS REMOVED, THE TROCAR CATHETER RETRACTED IN THE ABDOMINAL WALL, HOWEVER, THE PHYSICIAN WAS NO LONGER ABLE TO VISUALIZE THE TROCAR CATHETER. A SECOND ENDOVIVE STANDARD PEG KIT PULL METHOD WAS OBTAINED AND THE SAME EVENT OCCURED. THE TROCAR RETRACTED AGAIN AFTER THE NEEDLE WAS REMOVED. THE PROCEDURE WAS STOPPED. THE PATIENT WAS TAKEN TO RECOVERY AND THERE WERE NO UNTOWARD PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131480 ↗
• InjuryJun 25, 2021Leak/Splash; Device Dislodged or Dislocated; Leak/Splash; Device Dislodged or Dislocated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2021. POST PROCEDURE, THE PEG TUBE DISLODGED BETWEEN STOMACH WALL AND ABDOMINAL WALL WHICH CAUSED FOUR TO FIVE LITERS OF FEEDING SOLUTION TO LEAK IN THE ABDOMEN. THIS RESULTED IN THE PATIENT GETTING PERITONITIS AND SEPTIC SHOCK REQUIRING SURGERY TO FIX. IT WAS REPORTED THE PATIENT WENT INTO RENAL FAILURE. AS PER PHYSICIAN ASSESSMENT, THE DISLODGED PEG TUBE CONTRIBUTED TO THE PERITONITIS, SEPTIC SHOCK AND RENAL FAILURE. THE CONDITION OF THE PATIENT WAS REPORTED AS EXPECTED TO FULLY RECOVER.

  Patient problems: Peritonitis; Renal Failure; Septic Shock

  MAUDE report 12066038 ↗
• InjuryJun 18, 2021Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. DURING PROCEDURE, IT WAS NOTED THE NEEDLE WOULD NOT EXIT THE TROCAR. THE TROCAR WAS DAMAGED. IT WAS REPORTED THE PATIENT EXPERIENCED DISCOMFORT. THE PROCEDURE WAS STOPPED. ON THE SAME DAY THE PATIENT HAD ANOTHER PEG TUBE SURGICALLY PLACED. THE CONDITION OF THE PATIENT WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Discomfort

  MAUDE report 12024999 ↗
• MalfunctionMar 17, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AS THE PEG TUBE WAS BEING PULLED, THE BLUE PULLWIRE BROKE. FORCEPS WERE USED TO GRAB THE TIP OF THE PEG TUBE TO CONTINUE PLACEMENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845047 ↗
• MalfunctionFeb 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019, THE PEG TUBE BROKE. THE PATIENT BROUGHT THE PEG TUBE TO THE HOSPITAL. THE INTERNAL BOLSTER WAS MISSING. REPORTEDLY, THE DETACHED PORTION WAS NOT REMOVED. A NEW PEG TUBE WAS REPLACED (MANUFACTURER UNKNOWN.) THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8365937 ↗
• MalfunctionFeb 6, 2019Break; Detachment of Device or Device Component

  PATIENT HAD PEG, ENDOVIVE 20 FR, PLACED AND REPORTED APPROXIMATELY 4 MONTHS AFTERWARD TO PHYSICIAN THAT THE PEG BROKE. THE PATIENT BROUGHT THE PEG TO PHYSICIAN. THE INNER BALLOON STOPPER IS GONE, PRESUMABLY 'BROKEN OFF' INSIDE STOMACH. THE PATIENT HAD A NEW PEG PLACED AND NO HARM CAME TO THE PATIENT AS A RESULT OF THIS EVENT. THE DEVICE WAS SAVED TO BE RETURNED TO THE MANUFACTURER. MANUFACTURER RESPONSE FOR TUBES, GASTROINTESTINAL (AND ACCESSORIES), ENDOVIVE STANDARD PEG KIT (PER SITE REPORTER). THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8309750 ↗