BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER HNBR5.0-35-90-P-NS-RBT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER HNBR5.0-35-90-P-NS-RBT manufactured by Cook Inc.

Event Text Entries

[184634213] (b)(4). A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[184634214] As reported, during embolization of the uterine artery, a beacon tip torcon nb advantage angiographic catheter became stuck in the patient. As the user attempted to pull the device from the patient, it was unable to be removed and became tangled in the aorta. Additional access was obtained in the patient's "other" groin and an unknown snare was used to straighten and remove the catheter. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00659
MDR Report Key9861045
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-03-11
Date Mfgr Received2020-03-12
Date Added to Maude2020-03-20
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 ContactMRS. JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
Generic NameDQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
Product CodeDQO
Date Received2020-03-20
Catalog NumberHNBR5.0-35-90-P-NS-RBT
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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