RIGIFLEX II
Received Mar 25, 2025 · Event occurred Nov 1, 2006
Report 3005099803-2025-01215 · MDR key 21687784
Device
Generic name
Dilator, Esophageal
Manufacturer
Boston Scientific CorporationProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Chest Pain
- Perforation
- Chest Pain
- Perforation
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 STUDY PATIENTS EXPERIENCED COMPLICATIONS SUCH AS PERFORATIONS AND BENIGN CHEST PAINS. THESE COMPLICATIONS WERE ADDRESSED THROUGH SURGICAL INTERVENTION AND 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 IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF AN ADDITIONAL BALLOON DEVICE WAS USED. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED HOSPITALIZATION DUE TO BENIGN CHEST PAIN.