FDA.reportPublic FDA data

MAUDE MDR 9701368

MDR report key
9701368
Report number
2520313-2020-00004
Event key
0
Event type
3
Date of event
2020-01-27
Date received
2020-02-12
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#

Contact
DIANE ECKERT
Address
1 BAYER DRIVE INDIANOLA PA 15051 US
Phone
724-724-7249
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STELLANT DUAL CT INJECTORCT INJECTION SYSTEMBAYER MEDICAL CARE INC.DXT58746456SCT DN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1201. O

Event Narratives#

N

Patient 1

A SYSTEM SERVICE CHECK OF THE STELLANT CT INJECTOR, SERIAL NUMBER (B)(4), WAS COMPLETED ON JANUARY 29, 2020 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THERE WAS NO EVIDENCE OF EQUIPMENT MALFUNCTION. THE STELLANT DISPOSABLE SET THAT WAS IN USE DURING THE PROCEDURE WAS DISCARDED BY THE SITE; HOWEVER, THE LOT NUMBER THAT WAS IN USE DURING THE TIME OF THE INCIDENT WAS PROVIDED. BAYER PRODUCT ANALYSIS TESTED A RETAINED SAMPLE FROM SDS-CTP-QFT, LOT NUMBER 8572269. NO VISUAL OR FUNCTIONAL DEFECTS WERE IDENTIFIED. FUNCTIONAL TESTING CONCLUDED THAT THE RETAINED DISPOSABLES PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED; HOWEVER, THE SITE DECLINED. THE SITE CONTINUES TO USE THE STELLANT CT INJECTION SYSTEM AFTER THE REPORTED EVENT WITH NO FURTHER ISSUES REPORTED.

D

Patient 1

BAYER MEDICAL CARE WAS NOTIFIED OF AN EXTRAVASATION THAT OCCURRED DURING AN ENHANCED CT SCAN OF THE ABDOMEN AND PELVIS WHILE A PATIENT WAS CONNECTED TO A STELLANT CT INJECTION SYSTEM. THE CUSTOMER REPORTED THAT AN UNDISCLOSED AMOUNT OF CONTRAST EXTRAVASATED IN THE PATIENT'S RIGHT ANTECUBITAL SPACE DURING THE INJECTION. APPROXIMATELY 3 HOURS AFTER THE EXAM WAS COMPLETED, THE PATIENT CALLED THE FACILITY TO REPORT THAT THEIR RIGHT ARM WAS SWOLLEN AND PAINFUL. THE FACILITY STAFF REFERRED THE PATIENT TO THEIR PHYSICIAN AND AT THE TIME OF THE CALL RECOMMENDED APPLYING AN ICEPACK AND ELEVATING THE AFFECTED EXTREMITY. THE PATIENT WAS RE-EVALUATED THE FOLLOWING DAY AT THEIR SCHEDULED UROLOGY FOLLOW-UP APPOINTMENT AND, WHILE ON SITE, THE PHYSICIAN EXAMINED THE EXTREMITY AND NOTED THE PRESENCE OF NORMAL PULSES AND MILD INDURATION WITH NO EVIDENCE OF TISSUE DAMAGE. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY.