FDA.reportPublic FDA data

MAUDE MDR 5522823

MDR report key
5522823
Report number
2183502-2016-00605
Event key
0
Event type
3
Date of event
2016-02-22
Date received
2016-03-24
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#

Contact
MS. MICHELE SELIGA
Address
1265 GREY FOX RD. ST. PAUL MN 55112 US
Phone
763-763-7633
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PORT-A-CATH II INTRASPINAL ACCESS SYSTEMPORT/CATHETER, INTERNAL SUBCUTANEOUSSMITHS MEDICAL ASD INC.,LNYNA21-1500-22NIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-2401. R

Event Narratives#

N

Patient 1

CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

D

Patient 1

FROM CLINICAL TRIAL STUDY ORGANIZER: IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN PATIENT FOR ADMINISTRATION OF CLINICAL TRIAL DRUG. ACCORDING TO REPORTER, A CONTRAST STUDY ON (B)(6) 2016 SHOWED EXTRAVASATION FROM THE CATHETER AT THE LOWER LUMBAR. A LONG SPLIT WAS NOTED IN THE CATHETER. AN ATTEMPT WAS MADE AT CUTTING AND RECONNECTING THE CATHETER USING A CONNECTOR FROM THE LUMBAR DRAIN, BUT THE CONNECTOR WAS TOO BIG. THEREFORE, THE OLD PORT WAS REPLACED THE DEVICE WAS SURGICALLY EXPLANTED FROM PATIENT ON AN UNSCHEDULED BASIS (B)(6) 2016. CLINICAL TRIAL STUDY ORGANIZER REPORTED THAT THE ACCESS SYSTEM WAS REPLACED WITH ANOTHER SYSTEM AFTER EXPLANT. THE PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2016. NO PERMANENT ADVERSE EFFECTS REPORTED.