FDA.reportPublic FDA data

MAUDE MDR 7611003

MDR report key
7611003
Report number
1721279-2018-00074
Event key
0
Event type
3
Date of event
2018-05-22
Date received
2018-06-18
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. BARBARA CREEL
Address
9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US
Phone
719-719-7194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPECTRANETICS ELCA CORONARY ATHERECTOMY CATHETERELCATHE SPECTRANETICS CORPORATIONLPC114-009114-009FTT17J01A 269Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
02018-06-1801. H; 2. L; 3. R

Event Narratives#

No narrative records found.