HP TLC KIT 12 X 16CM CE
Received Aug 7, 2013 · Event occurred Jul 5, 2013
Report 1317749-2013-00255 · MDR key 3301793
Device
Generic name
Hp Tlc Kit 12 X 16cm Ce
Manufacturer
CovidienModel number
8888345629HPCatalog number
8888345629HP
Lot number
UNK
Product problems
- Kinked
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(4). 2013 THAT A CUSTOMER HAD AN ISSUE WITH HP TLC KIT 12 X 16CM CE. THE CUSTOMER STATES THAT THEY ATTEMPTED RIGHT FEMORAL MAHURKAR LINE PLACEMENT WITH ULTRASOUND GUIDANCE. PT WAS IN THE SUPINE DURING INSERTION, NO ABNORMAL RESISTANCE OR DIFFICULTY ENCOUNTERED WITH ADEQUATE RETURN OF VENOUS BLOOD VISUALIZED. NUMEROUS ATTEMPTS TO REMOVE THE GUIDE WIRE FAILED; UNABLE TO REMOVE THE GUIDE WIRE. CATHETER WAS REMOVED, LEAVING THE GUIDE WIRE IN. VISUALIZED WITH C-ARM, IT APPEARED KINKED. PT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR REMOVAL. NO COMPLICATIONS TO THE PT.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.