SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER 117-016

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 2018-06-13 for SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER 117-016 manufactured by The Spectranetics Corporation.

MAUDE Entry Details

Report Number1721279-2018-00073
MDR Report Key7596378
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-06-13
Date of Report2018-05-21
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2018-05-21
Date Added to Maude2018-06-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. BARBARA CREEL
Manufacturer Street9965 FEDERAL DRIVE
Manufacturer CityCOLORADO SPRINGS CO 80921
Manufacturer CountryUS
Manufacturer Postal80921
Manufacturer Phone719447-246
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER
Generic NameELCA
Product CodeLPC
Date Received2018-06-13
Model Number117-016
Catalog Number117-016
Lot NumberUNAVAILABLE
ID NumberNI
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTHE SPECTRANETICS CORPORATION
Manufacturer Address9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921


Patients

Patient NumberTreatmentOutcomeDate
001. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2018-06-13

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