T-DOC
Received Feb 27, 2015 · Event occurred Nov 13, 2014
Report 9681424-2015-00001 · MDR key 4645901
Device
Generic name
7fr Dual Sensor Catheter
Manufacturer
Laborie Medical Technologies Canada UlcModel number
T-DOC-7FDCatalog number
CAT880
Lot number
130912
Product problems
- Break
- Device Or Device Fragments Location Unknown
Patient
78 YR
- Vessel Or Plaque, Device Embedded In
Narrative
Additional Manufacturer Narrative
THE INITIAL REPORT FROM (B)(6) COMPETENT AUTHORITY FOR MEDICAL DEVICES WAS IN (B)(4) LANGUAGE, DIFFICULT TO UNDERSTAND AND PROVIDED LIMITED INFORMATION. ONCE WE RECEIVED BACK THE CATHETER ON FEBRUARY 19, 2015 WE WERE ABLE TO DETERMINE THIS INS A REPORTABLE EVENT. THE URODYNAMIC CATHETER RETURNED IS MISSING 8 CENTIMETERS (3.15 INCHES) OR LENGTH FROM THE URETHRAL PRESSURE SENSOR BALLOON TO THE DISTAL TIP OF THE CATHETER. WILL FOLLOW UP WITH CUSTOMER TO DETERMINE IF A RIGID SCOPE AND/OR ANY SURGICAL DEVICE OR INSTRUMENT WAS USED AT ANY TIME DURING THE URODYNAMIC PROCEDURE, INCLUDING DURING CATHETER INSERTION AND CATHETER WITHDRAWAL. THIS TO ENSURE THE CATHETER WAS NOT DAMAGED BY OTHER MEANS AT THE CUSTOMER'S LOCATION.
Description of Event or Problem
DURING URODYNAMIC DIAGNOSTIC PROCEDURE, THEN THE URODYNAMIC CATHETER WAS WITHDRAWN FROM THE PATIENT'S BLADDER, THE SENSOR WAS MISSING.
Remedial action
- Patient Monitoring