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

[83666605] Patient weight unavailable from facility. Device evaluation: during evaluation, the device's marker band appears to have cleanly disconnected from the catheter. No epoxy observed on the catheter.
Patient Sequence No: 1, Text Type: N, H10


[83666606] Tip came off elca catheter during procedure for occluded saphenous vein graft. Physician able to retrieve tip from patient. Patient discharged next day.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721279-2017-00180
MDR Report Key6821052
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-08-25
Date of Report2017-08-03
Date of Event2017-08-03
Date Mfgr Received2017-08-03
Device Manufacturer Date2017-04-17
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
Returned To Mfg2017-08-17
Model Number114-009
Catalog Number114-009
Lot NumberFTT17D17A
ID NumberNI
Device Expiration Date2019-04-20
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSPECTRANETICS
Manufacturer Address9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-08-25

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