inforMED
MalfunctionPID

RIGIFLEX II

Received Jul 25, 2023 · Event occurred Jul 6, 2023

Report 3005099803-2023-04014 · MDR key 17393704

Device

Generic name

Dilator, Esophageal

Model number

M00554500

Catalog number

5450

Lot number

C304517

Product problems

  • Burst Container or Vessel
  • Burst Container or Vessel

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A0402 CAPTURES THE REPORTABLE EVENT OF BALLOON BURST.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II BALLOON WAS USED IN THE LOWER ESOPHAGEAL SPHINCTER (LES) DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.