FDA.reportPublic FDA data

MAUDE MDR 3037276

MDR report key
3037276
Report number
3009124963-2013-00009
Event key
0
Event type
3
Date of event
2013-02-05
Date received
2013-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1001 ASBURY DR BUFFALO GROVE IL 60089 US
Phone
847-847-8474
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEO MAPCATH SENSOR STYLETNONECORPAK MEDSYSTEMSOMF0.8FR60-20084488R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-03-1801. O; 2. R

Event Narratives#

D

Patient 1

THE STYLET USED IN ADVANCING THE PICC LINE BROKE INTO TWO PIECES WHILE INSIDE THE PATIENT AND BECAME INTRAVASCULAR FOREIGN BODIES. EACH PIECE REQUIRED SURGICAL INTERVENTION (CARDIAC CATHETERIZATION) FOR REMOVAL. ACCORDING TO THE CUSTOMER THE STYLET WAS INSERTED INTO THE PICC PRIOR TO INSERTION. THE PICC WAS ALSO SHORTENED AS PART OF THE PROCEDURE. THE POSITION OF THE PICC WAS NOT VERIFIED BY THE NAVIGATOR SIGNAL BUT BY X-RAY. PER XRAY IT WAS FOUND THAT ONE PIECE WAS IN THE HEART WHILE THE OTHER WAS IN THE LIVER. BOTH WERE SUCCESSFULLY REMOVED WITHOUT INCIDENT.

N

Patient 1

THERE WAS NO REPORT OF PATIENT 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 MANUFACTURING OR DESIGN DEFECT WAS IDENTIFIED IN THE INVESTIGATION. THE CUSTOMER INDICATED THAT THE STYLET WAS NOT TESTED FOR SIGNAL INTEGRITY AND THERE WAS NO CLEAR SIGNAL DURING THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PICC LINE WAS CUT TO SHORTEN THE LENGTH. ALL OF THESE STEPS MAY HAVE CONTRIBUTED TO THIS FAILURE MODE.