ENDOVIVE SAFETY PEG KIT
Received Sep 26, 2025 · Event occurred Sep 2, 2025
Report 3005099803-2025-04848 · MDR key 23152434
Device
Generic name
Gastrointestinal Tubes With Enteral Specific Connectors
Manufacturer
Boston Scientific CorporationModel number
M00509020Catalog number
M00509020
Lot number
0037179064
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF PULL WIRE BREAK.
Description of Event or Problem
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) 2025. DURING THE PROCEDURE, THE PEG PULL WIRE BROKE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.