FDA.reportPublic FDA data

MAUDE MDR 8367488

MDR report key
8367488
Report number
3005704822-2019-00001
Event key
0
Event type
3
Date of event
2019-02-19
Date received
2019-02-25
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
MR. TROY TAYLOR
Address
1916 PALOMAR OAKS WAY SUITE 150 CARLSBAD CA 92008 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NIT-OCCLUD PDAPDA OCCLUDERPFM MEDICAL AGMAE1450761450761024829R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-2501. O

Event Narratives#

N

Patient 1

THERE WAS NO EFFECT ON THE PATIENT. IT CANNOT BE EXCLUDED THAT A PRODUCT DEFECT EXISTS.

D

Patient 1

THE PROXIMAL LOOP OF THE COIL WAS FRACTURED POSITIONING THE DEVICE ON THE DEFECT. THE DEVICE WAS PLACED ON THE DEFECT. IT WAS NOT NECESSARY TO REMOVE IT. REMOVING IT COULD HAVE LED TO COMPLICATIONS DUE TO THE DIMENSIONS OF THE PATIENT. THERE WAS A POTENTIAL RISK OF EMBOLIZATION. THIS EVEN OCCURED IN ARGENTINA USING A PRODUCT THAT IS SIMILARTO ONE MARKETED IN THE US (REF (B)(4)).