FDA.reportPublic FDA data

MAUDE MDR 4526138

MDR report key
4526138
Report number
4526138
Event key
0
Event type
3
Date received
2015-01-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*CARDIAC CATHETERIZATION KITMEDLINE INDUSTRIES, INC.OES**14JB4917 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-01-070

Event Narratives#

D

Patient 1

DURING SETUP FOR A LEFT HEART CATHETER PROCEDURE, PART OF THE PACK FOR SET UP - THE TIP OF A WIRE THAT GOES INTO A CATHETER - WAS OBSERVED TO BE BROKEN. IT LOOKED DISJOINTED. THIS HAD NO PATIENT AFFECT DUE TO THIS BEING SET UP PRIOR TO THE CASE. ALSO A NEW WIRE WAS USED THAT WAS NOT PART OF A PACK. IT WAS REPLACED WITH A .035 J WIRE FROM ANOTHER VENDOR (OUT OF CATHETER LAB STOCK) AND IT WORKED JUST FINE.