NEO MAPCATH SENSOR STYLET
Received Apr 15, 2013 · Event occurred Feb 5, 2013
Report 3009124963-2013-00011 · MDR key 3075015
Device
Generic name
Navigator Wire
Manufacturer
Corpak MedsystemsModel number
0.8FRCatalog number
60-2008
Lot number
4427
Product problems
- Break
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
EVENT DESCRIPTION: THE STYLET USED IN ADVANCING THE PICC LINE BROKE WHILE INSIDE THE PT AND BECAME AN INTRAVASCULAR FOREIGN BODY. THE PIECE REQUIRED SURGICAL INTERVENTION (CARDIAC CATHETERIZATION) FOR REMOVAL. THE "PIECE" WAS REMOVED WITHOUT INCIDENT. ACCORDING TO THE CUSTOMER, THE STYLET WAS INSERTED INTO THE PICC PRIOR TO INSERTION. THERE WAS NO REPORTED RESISTANCE UPON INSERTION OR REMOVAL. THE PICC LINE WAS SHORTENED PRIOR TO PLACING STYLET. ACCORDING TO THE CUSTOMER, THE PICC WAS NOT FLUSHED PRIOR TO STYLET REMOVAL.
Additional Manufacturer Narrative
THERE WAS NO REPORT OF PT INJURY. THE ACTUAL SAMPLE HAS NOT BEEN RETURNED. SAMPLES FROM THE SAME LOT WERE TESTED AT GREATER THAN 17N WHICH IS GREATER THAN ANY FORCE EXPECTED IN THE CLINICAL SETTING. NO MFG OR DESIGN DEFECT WAS IDENTIFIED IN THE INVESTIGATION. THE CLINICIAN DID NOT REPORT ANY DIFFICULTIES WITH STYLET INSERTION OR PICC PLACEMENT.