MalfunctionMZQ
VENT MANDREL DSB DETACHABLE SILICONE BALLOON
Received Sep 7, 2001 · Event occurred Aug 7, 2001
Report 6000078-2001-00054 · MDR key 351061
Device
Product problems
- Fracture
- Difficult to Insert
- Replace
Patient
NO INFO
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED TO BSC-TARGET THAT DURING THE PROCEDURE THE VENT MANDREL FRACTURED 1/2 WAY UP. A SECOND UNIT WAS USED AND PROCEDURE WAS SUCCESSFUL. PER ADDITIONAL INFORMATION REQUESTED THROUGH A COMPANY REPRESENTATIVE IN AUGUST 2001: "THE WIRE BROKE AS THE PHYSICIAN WAS PUTTING IT INTO THE CATHETER. IT BROKE HALFWAY UP THE SHAFT DEFINITELY PROXIMAL TO THE TUBING."