FDA.reportPublic FDA data

MAUDE MDR 9882747

MDR report key
9882747
Report number
9882747
Event key
0
Event type
3
Date of event
2020-01-10
Date received
2020-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1COOKCATHETER, PERCUTANEOUSCOOK INCORPORATEDDQYG03117C-PMS-301J-PED* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-260

Event Narratives#

D

Patient 1

CENTRAL VENOUS CATHETER WAS PLACED IN PATIENTS LIJV (LEFT INTERNAL JUGULAR VEIN). AFTER THE CATHETER WAS SUTURED IN PLACE THE CARDIAC CATH FELLOW ATTEMPTED TO FLUSH THE LINE. THIS ATTEMPT WAS UNSUCCESSFUL AND THE CATHETER APPEARED TO BE KINKED AT THE INCISION SITE. THE FELLOW ATTEMPTED TO STRAIGHTEN THE CATHETERS KINK IN HOPES THAT WOULD SOLVE THE OCCLUSION PROBLEM. ONCE THE CATHETER WAS STRAIGHTENED OUT IT APPEARED TO BREAK, LEAVING THE INTRAVASCULAR PORTION LODGED IN THE VEIN. DOCTOR WAS PAGED TO COME REMOVE THE RETAINED CATHETER. WHILE ATTEMPTING THE REMOVAL, THE RETAINED PORTION BROKE FREE AND TRAVELED TO THE PATIENTS RIGHT ATRIUM. ANOTHER DOCTOR THEN SUCCESSFULLY REMOVED THE BROKEN CATHETER FROM THE RIGHT ATRIUM USING A INTRAVASCULAR SNARE AND ANGIOGRAPHIC CATHETER. STAFF THEN PROCEEDED TO RECONSTRUCT THE PATIENTS LIJV. PATIENT NEEDED CENTRAL VENOUS ACCESS DURING CARDIAC CATH PROCEDURE. AFTER COLLECTING THE COMPONENTS OF THE CATHETER, THE TEAM FELT THEIR MAY HAVE BEEN A DEVICE FAILURE AS THESE CATHETERS GENERALLY HAVE MORE INTEGRITY. THE DEVICE WAS PLACED IN A BIOHAZARD BAG AND WILL BE SENT TO COOK MEDICAL.