PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER 60109-4060 M5IVL4060

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 2019-10-30 for PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER 60109-4060 M5IVL4060 manufactured by Shockwave Medical, Inc.

MAUDE Entry Details

Report Number3010940016-2019-00007
MDR Report Key9257784
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-30
Date of Report2019-10-01
Date of Event2019-10-01
Date Mfgr Received2019-10-01
Device Manufacturer Date2019-03-15
Date Added to Maude2019-10-30
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 Received2019-10-30
Returned To Mfg2019-10-08
Model Number60109-4060
Catalog NumberM5IVL4060
Lot NumberP190315G
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSHOCKWAVE MEDICAL, INC
Manufacturer Address5403 BETSY ROSS DRIVE SANTA CLARA CA 95054 US 95054


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-10-30

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