MalfunctionFEN

ABDOMINAL PRESSURE CATHETER 9F

Received Jan 19, 2012 · Event occurred Jan 4, 2012

Report MW5023897 · MDR key 2426042

Device

Generic name

Abdominal Pressure Catheter

Manufacturer

Life-tech Inc

Catalog number

RPC-9

Lot number

4K21502

Product problems

Device Dislodged or Dislocated

Patient

42 YR

Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

PT UNDERWENT AN OUTPATIENT CYSTOMETROGRAM. DURING PROCEDURE, CATHETER BALLOON DISLODGED WHILE CATHETER WAS IN RECTUM. PHYSICIAN UNABLE TO RETRIEVE BALLOON FROM RECTUM. NO OBVIOUS HARM TO PT. PT ADVISED BY PHYSICIAN THAT THE BALLOON WILL PASS IN BOWEL MOVEMENT.