APTUS HELI-FX SA-85

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-29 for APTUS HELI-FX SA-85 manufactured by Medtronic Vascular.

MAUDE Entry Details

Report Number9249407
MDR Report Key9249407
Date Received2019-10-29
Date of Report2019-10-21
Date of Event2019-10-18
Report Date2019-10-21
Date Reported to FDA2019-10-21
Date Reported to Mfgr2019-10-29
Date Added to Maude2019-10-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAPTUS HELI-FX
Generic NameENDOVASCULAR SUTURING SYSTEM
Product CodeOTD
Date Received2019-10-29
Model NumberSA-85
Catalog NumberSA-85
Lot Number0009714615
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC VASCULAR
Manufacturer Address3850 BRICKWAY BLVD SANTA ROSA CA 95403 US 95403


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-29

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