inforMED
MalfunctionPID

RIGIFLEX II

Received Apr 25, 2022 · Event occurred Apr 1, 2022

Report 3005099803-2022-02127 · MDR key 14194477

Device

Generic name

Dilator, Esophageal

Model number

M00554520

Catalog number

5452

Lot number

C030263

Product problems

  • Difficult to Advance
  • Material Twisted/Bent
  • Difficult to Advance
  • Material Twisted/Bent

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

(B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON WAS DIFFICULT TO ADVANCE CAUSING THE BALLOON TIP TO BE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RIGIFLEX II BALLOON . THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.