InjuryFFP
RIGIFLEX TTS ANASTOMATIC BALLOON CATHETER
Received Feb 7, 1994 · Event occurred Jan 31, 1994
Report 13062 · MDR key 13062
Device
Product problems
- Material Rupture
Patient
80 YR
- Pain
- Perforation
Narrative
Description of Event or Problem
PT SCHEDULED FOR OUTPATIENT COLONOSCOPY. THE 75 FRENCH PNEUMATIC DILATOR WAS PRIMED AND TESTED PRIOR TO THE START OF THE PROCEDURE. THE PROCEDURE STARTED AT 11:47 AM. WHEN THE BALLOON WAS INFLATED DURING THE PROCEDURE, IT RUPTURED. THE PROCEDURE ENDED AT 12/17 PM. THE PT DEVELOPED ABDOMINAL DISTENTION AND DISCOMFORT. FLAT PLATE AND LATERAL DECUBITUS X-RAYS OF ABDOMEN COMPLETED. AT 1:25 PM PT WAS TAKEN TO THE OR FOR EXPLORATORY LAPAROTOMY AND REPAIR OF COLONIC PERFORATION.