MalfunctionFEN
LATORIE
Received Mar 19, 2015 · Event occurred Mar 2, 2015
Report 9681424-2015-00003 · MDR key 4648808
Device
Generic name
Abdominal Pressure Catheter 9f
Manufacturer
Laborie Medical Technologies Canada UlcModel number
RPC-9Catalog number
RPC-9
Lot number
CM14119
Product problems
- Loss of or Failure to Bond
Patient
Not reported
- Foreign Body In Patient
Narrative
Description of Event or Problem
DURING A URODYNAMICS PROCEDURE, WHEN THE RECTAL BALLOON CATHETER WAS REMOVED FROM THE PATIENT AT THE END OF THE PROCEDURE, THE BALLOON PART SEPARATED FROM THE CATHETER AND REMAINED IN THE PATIENT. PATIENT WAS SENT NEXT DOOR TO THE SURGERY CENTER SO A PHYSICIAN COULD REMOVE THE BALLOON.
Remedial action
- Other