EndoVive Safety PEG Kit M00566470Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 08714729748397), received between Dec 29, 2016 and Feb 5, 2025 — classified as 1 death, 7 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (84 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 20, 2024Class IIOpen, 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-1515-2024 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Obstruction of Flow; Difficult to Advance; Obstruction of Flow; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED IN THE ESOPHAGUS AND STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, UPON INITIAL PLACEMENT OF THE DEVICE, THE PHYSICIAN TRIED TO PASS THE PUSH PEG TUBE OVER THE GUIDEWIRE, BUT THE TUBE WOULD NOT PASS DUE TO OBSTRUCTION WITHIN THE TUBE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 21314291 ↗
• MalfunctionNov 27, 2024Obstruction of Flow; Difficult to Advance; Material Deformation; Obstruction of Flow; Difficult to Advance; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENDOVIVE SAFETY PEG KIT PUSH METHOD USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FEEDING TUBE INSERTION AND EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2024. A PEG TUBE EXCHANGE WAS PERFORMED DUE TO LEAKAGE OF THE DEVICE THAT WAS PLACED THREE MONTHS PRIOR. DURING THE PROCEDURE, WHEN THE PHYSICIAN EXCHANGED THE TUBE, THE GUIDEWIRE WOULD NOT PASS THROUGH THE PEG TUBE DESPITE MANY EFFORTS. THEY TRIED CUTTING THE GUIDEWIRE TO REMOVE THE KINK AS WELL AS STRAIGHTENING AND MANEUVERING THE TUBE TO TRY TO GET THE WIRE TO PASS. A SECOND PEG KIT WAS OPENED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH AN 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 20790818 ↗
• MalfunctionNov 26, 2024Obstruction of Flow; Difficult to Advance; Material Deformation; Obstruction of Flow; Difficult to Advance; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ENDOVIVE SAFETY PEG KIT PUSH METHOD USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FEEDING TUBE INSERTION AND EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2024. A PEG TUBE EXCHANGE WAS PERFORMED DUE TO LEAKAGE OF THE DEVICE THAT WAS PLACED THREE MONTHS PRIOR. DURING THE PROCEDURE, WHEN THE PHYSICIAN EXCHANGED THE TUBE, THE GUIDEWIRE WOULD NOT PASS THROUGH THE PEG TUBE DESPITE MANY EFFORTS. THEY TRIED CUTTING THE GUIDEWIRE TO REMOVE THE KINK AS WELL AS STRAIGHTENING AND MANEUVERING THE TUBE TO TRY TO GET THE WIRE TO PASS. A SECOND PEG KIT WAS OPENED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH AN 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 20784743 ↗
• MalfunctionJul 5, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PEG KIT PUSH METHOD WOULD NOT PASS OVER THE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ENDOVIVE SAFETY PEG KIT PUSH METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF FEEDING TUBE OCCLUDED/BLOCKED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684391 ↗
• MalfunctionJul 5, 2024Obstruction of Flow; Obstruction of Flow

  BOSTON SCIENTIFIC RECEIVED AN ENDOVIVE SAFETY PEG KIT PUSH METHOD FROM (B)(6) HOSPITAL ON (B)(6) 2024. THERE WAS NO REPORTED ALLEGATION AGAINST THE DEVICE BUT, THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF FEEDING TUBE OCCLUDED/BLOCKED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND IT IS UNKNOWN IF THIS DEVICE WAS USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19683127 ↗
• MalfunctionMay 8, 2024Obstruction of Flow; Obstruction of Flow

  BOSTON SCIENTIFIC RECEIVED AN ENDOVIVE SAFETY PEG KIT PUSH METHOD FROM OSU MEDICAL CENTER ON (B)(6) 2024. THERE WAS NO REPORTED ALLEGATION AGAINST THE DEVICE BUT, THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF FEEDING TUBE OCCLUDED/BLOCKED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND IT IS UNKNOWN IF THIS DEVICE WAS USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273814 ↗
• MalfunctionMay 8, 2024Obstruction of Flow; Obstruction of Flow

  BOSTON SCIENTIFIC RECEIVED AN ENDOVIVE SAFETY PEG KIT PUSH METHOD ON FEBRUARY 28, 2024. THERE WAS NO REPORTED ALLEGATION AGAINST THE DEVICE BUT, THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF FEEDING TUBE OCCLUDED/BLOCKED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND IT IS UNKNOWN IF THIS DEVICE WAS USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271834 ↗
• MalfunctionMay 6, 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 PUSH METHOD WAS ATTEMPTED TO BE USED DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING INSERTION, THE PEG TUBE BROKE APART. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 19251260 ↗
• MalfunctionMay 6, 2024Obstruction of Flow; Obstruction of Flow

  BOSTON SCIENTIFIC RECEIVED AN ENDOVIVE SAFETY PEG KIT PUSH METHOD FROM (B)(6) 2024. THERE WAS NO REPORTED ALLEGATION AGAINST THE DEVICE BUT, THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF FEEDING TUBE OCCLUDED/BLOCKED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND IT IS UNKNOWN IF THIS DEVICE WAS USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249613 ↗
• MalfunctionMay 1, 2024Obstruction of Flow; Obstruction of Flow

  BOSTON SCIENTIFIC RECEIVED AN ENDOVIVE SAFETY PEG KIT PUSH METHOD ON (B)(6) 2024. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: TUBE FEEDING OCCLUDED/BLOCKED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. THERE WAS NO PATIENT INVOLVEMENT, AND THIS DEVICE WAS NOT USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226815 ↗
• MalfunctionApr 30, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE PEG TUBE, THE INNER LUMEN WAS OBSTRUCTED. THEY LOOKED INTO THE TUBE AND COULD NOT SEE AN OPENING. SEEMS LIKE IT WAS SEALED AT THE JUNCTION POINT OF THE LEADING TAPERED TUBE AND G-TUBE. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PUSH METHOD PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214737 ↗
• MalfunctionApr 30, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE PEG TUBE, THE INNER LUMEN WAS OBSTRUCTED. THEY LOOKED INTO THE TUBE AND COULD NOT SEE AN OPENING. SEEMS LIKE IT WAS SEALED AT THE JUNCTION POINT OF THE LEADING TAPERED TUBE AND G-TUBE. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PUSH METHOD PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214734 ↗
• MalfunctionApr 30, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE PEG TUBE, THE INNER LUMEN WAS OBSTRUCTED. THEY LOOKED INTO THE TUBE AND COULD NOT SEE AN OPENING. SEEMS LIKE IT WAS SEALED AT THE JUNCTION POINT OF THE LEADING TAPERED TUBE AND G-TUBE. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PUSH METHOD PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214731 ↗
• MalfunctionApr 26, 2024Obstruction of Flow; Obstruction of Flow

  BOSTON SCIENTIFIC RECEIVED AN ENDOVIVE SAFETY PEG KIT PUSH METHOD ON (B)(6) 2024. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: TUBE FEEDING OCCLUDED/BLOCKED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. THERE WAS NO PATIENT INVOLVEMENT, AND THIS DEVICE WAS NOT USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197625 ↗
• MalfunctionApr 24, 2024Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED AN ENDOVIVE SAFETY PEG KIT PUSH METHOD ON FEBRUARY 28, 2024. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: TUBE FEEDING OCCLUDED/BLOCKED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS. THERE WAS NO PATIENT INVOLVEMENT, AND THIS DEVICE WAS NOT USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176476 ↗
• MalfunctionApr 1, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT ADVANCE THE GUIDEWIRE THROUGH THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT AND A SECOND PEG KIT PUSH METHOD WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 19015895 ↗
• MalfunctionMar 19, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. A SECOND PEG KIT WAS OPENED AND ATTEMPTED TO BE USED BUT, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938384 ↗
• MalfunctionMar 19, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. A SECOND PEG KIT WAS OPENED AND ATTEMPTED TO BE USED BUT, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938382 ↗
• MalfunctionMar 13, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) FEEDING TUBE INSERTION PROCEDURE. THE EXACT PROCEDURE WAS UNKNOWN. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE PROCEDURE WAS COMPLETED WITH A SECOND 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 18899494 ↗
• MalfunctionMar 11, 2024Obstruction of Flow; Obstruction of Flow

  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) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE PROCEDURE WAS COMPLETED WITH A SECOND 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 18882620 ↗
• MalfunctionMar 11, 2024Obstruction of Flow; Obstruction of Flow

  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) 2024. DURING THE PROCEDURE, THE GUIDEWIRE WAS UNABLE TO PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE PROCEDURE WAS COMPLETED WITH A SECOND 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 18882614 ↗
• MalfunctionMar 7, 2024Obstruction of Flow; Obstruction of Flow

  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) 2024. DURING THE PROCEDURE, THE GUIDEWIRE WAS UNABLE TO PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE PROCEDURE WAS COMPLETED WITH A PULL METHOD PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861342 ↗
• MalfunctionMar 7, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF THREE ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE THIRD PULL METHOD PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 08, 2024: IT WAS REPORTED THAT THEY ONLY HAD PROBLEMS WITH TWO ENDOVIVE SAFETY PEG KIT PUSH METHOD AND COMPLETED THE PROCEDURE WITH A PULL METHOD PEG KIT. THERE ARE NO COMPLAINT ALLEGATIONS ON THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18860826 ↗
• MalfunctionMar 7, 2024Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE THIRD PULL METHOD PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18860721 ↗
• MalfunctionMar 7, 2024Obstruction of Flow; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE ENDOVIVE SAFETY PEG KITS PUSH METHOD THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PUSH METHOD WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE TRANSITION ZONE BETWEEN THE CONNECTOR, BETWEEN THE HARD AND SOFT PLASTIC. THE CUSTOMER REPORTED THAT TWO ADDITIONAL PEG KITS WERE OPENED AND ATTEMPTED TO BE USED BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH THE THIRD PULL METHOD PEG KIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 08, 2024: IT WAS REPORTED THAT THEY ONLY HAD PROBLEMS WITH TWO ENDOVIVE SAFETY PEG KIT PUSH METHOD AND COMPLETED THE PROCEDURE WITH A PULL METHOD PEG KIT. THERE ARE NO COMPLAINT ALLEGATIONS ON THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18860538 ↗