EndoVive Standard PEG Kit M00568210Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729748694), received between Aug 21, 2017 and Mar 1, 2024 — classified as 9 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 20, 2024Open, Classified

   Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration

   Z-1516-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Unraveled Material; Obstruction of Flow; Unraveled Material; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE PEG TUBE OVER THE GUIDEWIRE; HOWEVER, RESISTANCE WAS MET. HE TRIED TO WET THE GUIDEWIRE AND STRAIGHTEN THE TUBE, BUT IT WOULD NOT ADVANCE ALL THE WAY THROUGH THE PEG TUBE. EVENTUALLY, HE WAS ABLE TO GET THE TUBE THROUGH THE INCISION, BUT THE GUIDEWIRE COMPLETELY UNRAVELED IN THE PROCESS. IT WAS REPORTED THAT THE GUIDEWIRE WAS STUCK IN THE TRANSITION ZONE. THE PROCEDURE WAS COMPLETED WITH THE SAME ORIGINAL ENDOVIVE STANDARD 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 18820170 ↗
• MalfunctionNov 27, 2023Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO ENDOVIVE STANDARD PEG KIT PUSH METHOD USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT WHEN ATTEMPTING TO PUSH THE PEG TUBE, THE GUIDEWIRE WOULD NOT PASS THROUGH AS THE HOLE WAS CLOSED AND WAY TOO SMALL FOR THE WIRE. A SECOND PEG KIT WAS OPENED AND HAD THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD 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 18213133 ↗
• MalfunctionNov 27, 2023Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ENDOVIVE STANDARD PEG KIT PUSH METHOD USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT WHEN ATTEMPTING TO PUSH THE PEG TUBE, THE GUIDEWIRE WOULD NOT PASS THROUGH AS THE HOLE WAS CLOSED AND WAY TOO SMALL FOR THE WIRE. A SECOND PEG KIT WAS OPENED AND HAD THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD 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 18213132 ↗
• MalfunctionNov 9, 2023Obstruction of Flow; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO ENDOVIVE STANDARD PEG KIT PUSH METHOD USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INSERTION PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT THE GUIDEWIRE WOULD NOT PASS THROUGH THE PEG TUBE. A SECOND PEG KIT WAS OPENED AND HAD THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE STANDARD 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 18107051 ↗
• MalfunctionNov 9, 2023Obstruction of Flow; Difficult to Advance; Obstruction of Flow; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ENDOVIVE STANDARD PEG KIT PUSH METHOD USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INSERTION PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT THE GUIDEWIRE WOULD NOT PASS THROUGH THE PEG TUBE. A SECOND PEG KIT WAS OPENED AND HAD THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE STANDARD 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 18107030 ↗
• MalfunctionOct 27, 2023Obstruction of Flow; Difficult to Advance; Obstruction of Flow; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ENDOVIVE STANDARD PEG KIT PUSH METHOD USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED THAT WHEN ATTEMPTING TO PUSH THE PEG TUBE OVER THE WIRE, THE GUIDEWIRE WOULD NOT PASS THROUGH WHERE THE INTRODUCER MEETS THE PEG TUBE. A SECOND PEG KIT WAS OPENED AND HAD THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO FURTHER DEVICES WERE USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023291 ↗
• MalfunctionOct 6, 2023Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE ENDOVIVE STANDARD PEG KIT PUSH USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6), 2023. IT WAS REPORTED THAT WHEN ATTEMPTING TO PUSH THE PEG TUBE OVER THE WIRE, IT KEPT GETTING STUCK WHERE THE INTRODUCER MEETS THE PEG TUBE. AFTER MULTIPLE ATTEMPTS TO REMOVE THE PEG TUBE WHICH WAS STUCK ON THE WIRE. THE WIRE BECAME UNRAVELED AND STRETCHED. THE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND PEG KIT PUSH METHOD WAS OPENED HOWEVER THE SAME THING HAPPENED. THE PHYSICIAN THEN USED AN ENDOVIVE STANDARD PULL KIT TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, A THIRD ENDOVIVE STANDARD PEG PUSH TUBE WITH THE SAME LOT WAS OPENED AND THE SAME THING OCCURRED WITH THE ONES USED PREVIOUSLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890233 ↗
• MalfunctionOct 6, 2023Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE ENDOVIVE STANDARD PEG KIT PUSH USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT WHEN ATTEMPTING TO PUSH THE PEG TUBE OVER THE WIRE, IT KEPT GETTING STUCK WHERE THE INTRODUCER MEETS THE PEG TUBE. AFTER MULTIPLE ATTEMPTS TO REMOVE THE PEG TUBE WHICH WAS STUCK ON THE WIRE. THE WIRE BECAME UNRAVELED AND STRETCHED. THE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND PEG KIT PUSH METHOD WAS OPENED HOWEVER THE SAME THING HAPPENED. THE PHYSICIAN THEN USED AN ENDOVIVE STANDARD PULL KIT TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, A THIRD ENDOVIVE STANDARD PEG PUSH TUBE WITH THE SAME LOT WAS OPENED AND THE SAME THING OCCURRED WITH THE ONES USED PREVIOUSLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890229 ↗
• MalfunctionOct 6, 2023Entrapment of Device; Entrapment of Device

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE ENDOVIVE STANDARD PEG KIT PUSH USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT WHEN ATTEMPTING TO PUSH THE PEG TUBE OVER THE WIRE, IT KEPT GETTING STUCK WHERE THE INTRODUCER MEETS THE PEG TUBE. AFTER MULTIPLE ATTEMPTS TO REMOVE THE PEG TUBE WHICH WAS STUCK ON THE WIRE. THE WIRE BECAME UNRAVELED AND STRETCHED. THE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND PEG KIT PUSH METHOD WAS OPENED HOWEVER THE SAME THING HAPPENED. THE PHYSICIAN THEN USED AN ENDOVIVE STANDARD PULL KIT TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, A THIRD ENDOVIVE STANDARD PEG PUSH TUBE WITH THE SAME LOT WAS OPENED AND THE SAME THING OCCURRED WITH THE ONES USED PREVIOUSLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890227 ↗
• MalfunctionAug 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG PUSH METHOD TUBE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, WHEN PHYSICIAN TRIED TO PULL THROUGH THE STOMACH, THE PEG TUBE BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG PUSH METHOD. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237415 ↗
• MalfunctionJul 26, 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 PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE PEG TUBE DETACHED WHILE IT WAS PULLED THROUGH ABDOMEN. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD 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 15103369 ↗
• MalfunctionMay 5, 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 PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2022. DURING PROCEDURE, THE PEG TUBE DETACHED AT THE TRANSITION ZONE. THE PROCEDURE WAS COMPLETED WITH SAME ORIGINAL ENDOVIVE STANDARD 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 14294480 ↗
• InjuryApr 11, 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 PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PEG TUBE BROKE AT THE TRANSITION ZONE AS IT WAS BEING INSERTED THROUGH THE PATIENT'S MOUTH UP TO THE STOMA SITE. THE PEG TUBE HAD NOT GONE THROUGH THE STOMA AND WAS STUCK IN THE GASTRIC SIDE. IT WAS REPORTED THAT THE DETACHED PORTION WAS ENDOSCOPICALLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD 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 14074220 ↗
• MalfunctionJan 7, 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 PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE (B)(6) 2021. DURING THE PROCEDURE, THE PEG TUBE SEPARATED AT THE CONNECTOR WHILE PHYSICIAN WAS PULLING IT THROUGH THE ABDOMEN. THE PHYSICIAN WAS ABLE TO ADVANCE THE TUBE UTILIZING SURGICAL FORCEPS. 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 13193089 ↗
• InjuryDec 8, 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 PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE ON (B)(6) 2021. DURING PROCEDURE, WHEN PHYSICIAN WAS PULLING THE PEG TUBE THROUGH THE INCISION, IT BROKE. THE PHYSICIAN RETRIEVED THE TUBE AND PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG KIT PUSH METHOD. IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO A PATIENT THAT WAS IN THE ICU. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960351 ↗
• MalfunctionNov 8, 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 WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. ON (B)(6) 2021, THE PEG TUBE WAS LEAKING ENTERAL FEEDING NUTRITION FORMULA AND WHEN FLUSHED IT LEAKED FROM THE SITE. A CT SCAN WAS PERFORMED AND IT WAS NOTED THAT THE PEG TUBE WAS DISLODGED WITH THE BOLSTER IN THE SUBCUTANEOUS SOFT TISSUES AND OUTSIDE THE LUMEN OF THE STOMACH. ON (B)(6) 2021, IT WAS REPLACED WITH A NON-BOSTON SCIENTIFIC PEG TUBE. IT WAS REPORTED THAT PATIENT WAS GIVEN IV ANTIBIOTICS FOR FIVE DAYS TO PREVENT ANY ABDOMINAL WALL INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775193 ↗
• InjuryJul 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO TWO ENDOVIVE STANDARD PEG KITS PUSH METHOD USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2021-03827 AND 3005099803-2021-03828 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE PEG TUBE TORE IN HALF WHEN PULLING IT THROUGH THE STOMA SITE. IT WAS REPORTED THAT A PART OF THE DEVICE DETACHED INSIDE THE PATIENT AND WAS RETRIEVED. A SECOND PEG TUBE WAS USED AND THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE STANDARD 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 12238393 ↗
• InjuryJul 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO TWO ENDOVIVE STANDARD PEG KITS PUSH METHOD USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2021-03827 AND 3005099803-2021-03828 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE PEG TUBE TORE IN HALF WHEN PULLING IT THROUGH THE STOMA SITE. IT WAS REPORTED THAT A PART OF THE DEVICE DETACHED INSIDE THE PATIENT AND WAS RETRIEVED. A SECOND PEG TUBE WAS USED AND THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE STANDARD 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 12238392 ↗
• InjuryJul 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO TWO ENDOVIVE STANDARD PEG KITS PUSH METHOD USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2021-03567 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE PEG TUBE WAS DETACHED. IT WAS REPORTED THAT A PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT AND WAS RETRIEVED. A SECOND PEG TUBE WAS USED AND THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE STANDARD 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 12173623 ↗
• InjuryJul 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO TWO ENDOVIVE STANDARD PEG KITS PUSH METHOD USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2021-03568 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE PEG TUBE WAS DETACHED. IT WAS REPORTED THAT A PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT AND WAS RETRIEVED. A SECOND PEG TUBE WAS USED AND THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITH A THIRD ENDOVIVE STANDARD 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 12173612 ↗
• InjuryJul 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG PUSH METHOD WAS USED DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE PEG TUBE BROKE WHILE BEING PULLED THROUGH THE GASTRIC WALL. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE THROUGH SURGICAL METHODS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158467 ↗
• InjuryMay 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG PUSH METHOD WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE PEG TUBE WAS BROKE. IT WAS REPORTED THAT A PART OF THE DEVICE WAS DETACHED INSIDE THE PATIENT AND WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870846 ↗
• MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PLACEMENT PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, WHEN PEG TUBE WAS PLACED, THE JUNCTION BETWEEN THE HARD END AND SOFTER PIECE WAS BROKEN. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821046 ↗
• MalfunctionApr 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG PUSH METHOD WAS PLACED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PEG TUBE SPLIT INSIDE THE PATIENT. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD PEG PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629025 ↗
• MalfunctionMay 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS PLACING THE PEG TUBE, IT PULLED APART. THE PROCEDURE WAS COMPLETED WITH A NEW ENDOVIVE STANDARD 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 10075322 ↗