ANGIOGRAPHIC CATHETER UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2017-10-13 for ANGIOGRAPHIC CATHETER UNKNOWN manufactured by Cook Inc.

Event Text Entries

[89291533] Suspect device details: 350 to 510 micron poly vinyl alcohol (pva) particles common name: agents embolic product code: naj (b)(6). (b)(4). 510k: k081768. The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[89291534] It was discovered during a literature review of an observational study titled "liver abscess formation following transarterial chemoembolization" related to a retrospective review of patients from 2005 to 2013, that liver abscesses were found in 21 out of 3613 patients who had undergone a transarterial chemoembolization (tace) procedure. The patients had hepatic malignancies. Among the 21 patients, 15 were males and 6 were females, ranging in age from 41 to 73 years (mean 54. 6)
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2017-03266
MDR Report Key6947729
Report SourceLITERATURE
Date Received2017-10-13
Date of Report2017-12-07
Date of Event2016-04-04
Date Mfgr Received2017-11-09
Date Added to Maude2017-10-13
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 FDA3
Event Location3
Manufacturer ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANGIOGRAPHIC CATHETER
Generic NameAGENTS EMBOLIC PRODUCT CODE
Product CodeNAJ
Date Received2017-10-13
Catalog NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-10-13

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