54 FR MALONEY DILATOR BOUGIE
Received Jan 8, 2025 · Event occurred Nov 12, 2024
Report MW5164475 · MDR key 21113281
Device
Generic name
Bougie, Esophageal, And Gastrointestinal, Gastro-urology
Manufacturer
Teleflex MedicalCatalog number
507954
Patient
66 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
AN ECD DILATION OF A SCHATZKI'S RING WAS PERFORMED ON (B)(6) 2024, ON A 66-YEAR-OLD PATIENT. A 54 FR MALONEY DILATOR (ESOPHAGEAL BOUGIE) WAS INTRODUCED FOR DILATION AND THE DIAMETER WAS PROGRESSIVELY INCREASED TO 60 FR. SORE THROAT AND HOARSENESS PRESENTED POST-PROCEDURE. ON (B)(6) 2024, PATIENT VISITED PRIMARY CARE PHYSICIAN FOR INABILITY TO SPEAK. PHYSICIAN SUSPECTED THAT INJURY IS DUE TO ECD PROCEDURE AND NOT A VIRUS. PATIENT VISITED THE ER ON (B)(6) 2024, FOR DIFFICULTY BREATHING AND LOSS OF ABILITY TO SPEAK. LARYNGOSCOPY REVEALED INFLAMED VOCAL CORDS POSSIBLY DUE TO AN INCREASE IN REFLUX CAUSED BY THE ECD PROCEDURE. PATIENT VISITED ENT ON (B)(6) 2024, AND LARYNGOSCOPY CONFIRMED INFLAMED VOCAL CORDS RESULTED FROM A COMBINATION OF INCREASED ACID REFLUX DUE TO THE DILATION, AND INTUBATION DURING THE PROCEDURE. LOSS OF VOICE CAUSED BY AN INCREASE IN ACID REFLUX AFTER ECD DILATION, AND INTUBATION DURING THE ECD PROCEDURE.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 1/10/2025 FOR REPORT MW5164475 TO ADD CATALOG NUMBER.