SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER 114-009

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 2017-08-25 for SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER 114-009 manufactured by Spectranetics.

Event Text Entries

[83645812] Patient date of birth and weight unavailable from facility.
Patient Sequence No: 1, Text Type: N, H10


[83645813] Procedure performed to treat a lesion in the circumflex artery. A elca catheter was used for the treatment. During the procedure, a perforation occurred. The perforation was treated successfully; the patient survived the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721279-2017-00178
MDR Report Key6820445
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-08-25
Date of Report2017-07-31
Date of Event2017-07-19
Date Mfgr Received2017-07-31
Device Manufacturer Date2016-12-09
Date Added to Maude2017-08-25
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 ContactMRS. BARBARA CREEL
Manufacturer Street9965 FEDERAL DRIVE
Manufacturer CityCOLORADO SPRINGS CO 80921
Manufacturer CountryUS
Manufacturer Postal80921
Manufacturer Phone719447-246
Manufacturer G1SPECTRANETICS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETER
Generic NameELCA
Product CodeLPC
Date Received2017-08-25
Model Number114-009
Catalog Number114-009
Lot NumberFTT16M09A
ID NumberNI
Device Expiration Date2018-12-12
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSPECTRANETICS
Manufacturer Address9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2017-08-25

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