NBCA LIQUID EMBOLIC KIT 631XXX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-03-05 for NBCA LIQUID EMBOLIC KIT 631XXX manufactured by Cordis Neurovascular, Inc..

Event Text Entries

[20838711] During an embolization of an arterio-venous malformation the nbca glue migrated and resulted in pulmonary embolization. It was initially reported by a patient's mother that trufill dcs detachable coils were placed in the cerebral artery aneurysm and during the procedure the nbca glue went the wrong way into the blood stream. Treatment included aspirin 81mg, three times daily; ranitidine 150mg tablet, twice daily p. O. A few days later the patient saw both a cardiologist and pulmonologist. The cardiologist medically cleared the child and no treatment was prescribed. The child is to continue under pulmonologist's care and is to have a lung scan for follow-up care. He remains asymptomatic. The patient will see the neurosurgeon for another trufill dcs coil insertion in couple of weeks. The case was a right thalamic avm with drainage in a dilated vein of galen. It was reported by the physician that the event of glue pulmonary embolization probably happened on the first injection of nbca (25 %: 1. 2 cc). It was a feeder arising from the postero lateral choroidal branch. It was not a large and had a small network interpose before venous drainage and also it did not appear extremely high flow. The first part of the nbca deposition suddenly broke loose from the microcatheter and migrated very fast through the draining vein passing through the dural sinuses. Then, injection was halted for a few seconds and the injection was restarted completing the casting of the pedicle with some additional nbca. The catheter was pulled without problems. A few minutes after there was a brief cough response from the patient. During this procedure there were two additional uneventful glue depositions. The patient is neurologically intact. It was reported by the physician that there are no respiratory or cardiovascular issues noted. The patient was discharged two days after procedure. Additional information will be submitted within 30 days upon receipt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1058196-2008-00072
MDR Report Key1008190
Report Source05,07
Date Received2008-03-05
Date of Report2008-02-07
Date of Event2008-01-31
Date Mfgr Received2008-02-07
Date Added to Maude2008-03-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDR. GAURANG PATEL
Manufacturer StreetCORDIS CORPORATION 14201 N.W. 60TH AVENUE
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal33014
Manufacturer Phone7863136240
Manufacturer G1CORDIS NEUROVASCULAR, INC.
Manufacturer Street14700 NW 57TH COURT
Manufacturer CityMIAMI LAKES FL 33014
Manufacturer CountryUS
Manufacturer Postal Code33014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNBCA LIQUID EMBOLIC KIT
Generic NameCNV NBCA (MFE)
Product CodeKGG
Date Received2008-03-05
Model NumberNA
Catalog Number631XXX
Lot NumberUNK
ID NumberPART #: NA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key977569
ManufacturerCORDIS NEUROVASCULAR, INC.
Manufacturer AddressMIAMI LAKES FL 33014 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-03-05

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