MALONEY TUNGSTEN FILLED BOUGIE 54F
Received Feb 6, 2025 · Event occurred Nov 12, 2024
Report 3004365956-2025-00008 · MDR key 21322589
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Unknown
- Sore Throat
- Sore Throat
Narrative
Additional Manufacturer Narrative
QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS REPORTED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
Description of Event or Problem
IT WAS REPORTED VIA A MEDWATCH REPORT THAT AN ECD DILATION OF A RING WAS PERFORMED 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. FOLLOWING THE PROCEDURE, THE PATIENT VISITED PRIMARY CARE PHYSICIAN FOR INABILITY TO SPEAK. PHYSICIAN SUSPECTED THAT INJURY IS DUE TO ECD PROCEDURE AND NOT A VIRUS. PATIENT THEN VISITED THE EMERGENCY ROOM 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 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". ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS HEALTH CONSEQUENCES FOR THE PATIENT, "YES. PATIENT IS UNABLE TO SPEAK DUE TO VOCAL CORD DAMAGE. THE PATIENT IS CURRENTLY UNDER THE CARE OF AN ENT SPECIALIST. THE INJURY HAS NOT BEEN RESOLVED. PATIENT IS UNABLE TO SPEAK AND AWAITING FURTHER TESTING AND SPEECH THERAPY".
Description of Event or Problem
IT WAS REPORTED VIA A MEDWATCH REPORT THAT AN ECD DILATION OF A RING WAS PERFORMED 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. FOLLOWING THE PROCEDURE, THE PATIENT VISITED PRIMARY CARE PHYSICIAN FOR INABILITY TO SPEAK. PHYSICIAN SUSPECTED THAT INJURY IS DUE TO ECD PROCEDURE AND NOT A VIRUS. PATIENT THEN VISITED THE EMERGENCY ROOM 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 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". ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS HEALTH CONSEQUENCES FOR THE PATIENT, "YES. PATIENT IS UNABLE TO SPEAK DUE TO VOCAL CORD DAMAGE. THE PATIENT IS CURRENTLY UNDER THE CARE OF AN ENT SPECIALIST. THE INJURY HAS NOT BEEN RESOLVED. PATIENT IS UNABLE TO SPEAK AND AWAITING FURTHER TESTING AND SPEECH THERAPY".
Additional Manufacturer Narrative
(B)(4). CORRECTION SECTION B.1: "PRODUCT PROBLEM" WAS CHECKED IN ERROR. THERE WAS NO MALFUNCTION REPORTED WITH THE DEVICE.