SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER 10438577

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER 10438577 manufactured by Biosense Webster Inc.

MAUDE Entry Details

Report Number3009498591-2020-00002
MDR Report Key9688691
Date Received2020-02-10
Date of Report2020-02-10
Date of Event2020-01-14
Date Facility Aware2020-01-15
Report Date2020-02-10
Date Reported to FDA2020-02-10
Date Added to Maude2020-02-10
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
Generic NameCATHETER, ULTRASOUND, INTRAVASCULAR
Product CodeOBJ
Date Received2020-02-10
Model Number10438577
Catalog Number10438577
Lot NumberE5077951
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBIOSENSE WEBSTER INC
Manufacturer Address33 TECHNOLOGY DRIVE IRVINE, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-02-10

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