PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER 61925-7060 M5IVL7060

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-30 for PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER 61925-7060 M5IVL7060 manufactured by Shockwave Medical, Inc..

MAUDE Entry Details

Report Number3010940016-2019-00004
MDR Report Key8841967
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-07-30
Date of Report2019-07-30
Date of Event2019-07-01
Device Manufacturer Date2019-02-26
Date Added to Maude2019-07-30
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. RYAN KIRTLAND
Manufacturer Street5403 BETSY ROSS DRIVE
Manufacturer CitySANTA CLARA CA 95054
Manufacturer CountryUS
Manufacturer Postal95054
Manufacturer Phone4085502607
Manufacturer G1SHOCKWAVE MEDICAL, INC.
Manufacturer Street5403 BETSY ROSS DRIVE
Manufacturer CitySANTA CLARA CA 95054
Manufacturer CountryUS
Manufacturer Postal Code95054
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
Generic NameBALLOON CATHETER
Product CodePPN
Date Received2019-07-30
Model Number61925-7060
Catalog NumberM5IVL7060
Lot NumberBP190226F
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSHOCKWAVE MEDICAL, INC.
Manufacturer Address5403 BETSY ROSS DRIVE SANTA CLARA CA 95054 US 95054


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-30

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