inforMED
DeathPID

RIGIFLEX II

Received Mar 25, 2025 · Event occurred Nov 1, 2006

Report 3005099803-2025-01243 · MDR key 21687785

Device

Generic name

Dilator, Esophageal

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Perforation
  • Sepsis
  • Perforation
  • Sepsis

Narrative

Description of Event or Problem

BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING RIGIFLEX II BALLOON THROUGH THE ARTICLE TITLED, "SAFETY OF PNEUMATIC DILATION IN OLDER ADULTS WITH ACHALASIA: AN INTERNATIONAL MULTICENTER CROSS-SECTIONAL STUDY", BY NIR BAR ET. AL. PER THE ARTICLE, BETWEEN NOVEMBER 2006 TO OCTOBER 2020 THE PATIENT EXPERIENCED PERFORATION WHICH RESULTED IN DEATH FROM SEPSIS 3 MONTHS AFTER THE PERFORATION WAS SEALED USING AN OVER THE SCOPE CLIP AND A LONG HOSPITALIZATION. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS AND FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

Additional Manufacturer Narrative

BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE NOVEMBER 1, 2006, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN NOVEMBER 2006 AND OCTOBER 2020. BLOCK D4, H4: THE SUSPECT DEVICE LOT NUMBER AND UPN WERE NOT REPORTED. THEREFORE, THE UNIQUE IDENTIFIER (UDI) NUMBER, MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: NIR BAR, ET AL., "SAFETY OF PNEUMATIC DILATION IN OLDER ADULTS WITH ACHALASIA: AN INTERNATIONAL MULTICENTER CROSS-SECTIONAL STUDY" GASTROENTEROLOGY AND HEPATOLOGY DEPARTMENT, TEL AVIV MEDICAL CENTER, TEL AVIV FACULTY OF MEDICINE, TEL AVIV UNIVERSITY, TEL AVIV 6423906, HTTPS://DOI.ORG/10.3390/JCM12206682. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF AN ESOPHAGEAL PERFORATION. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF AN ADDITIONAL DEVICE REQUIRED TO SEAL THE PERFORATION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION DUE TO PERFORATION.