SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH 545-513

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 2019-11-14 for SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH 545-513 manufactured by The Spectranetics Corporation.

MAUDE Entry Details

Report Number1721279-2019-00190
MDR Report Key9322033
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-14
Date of Report2019-10-18
Date of Event2019-10-18
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2019-10-18
Device Manufacturer Date2019-09-14
Date Added to Maude2019-11-14
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
Generic NameTIGHTRAIL
Product CodeDRE
Date Received2019-11-14
Returned To Mfg2019-10-22
Model Number545-513
Catalog Number545-513
Lot NumberFRJ19J14A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerTHE SPECTRANETICS CORPORATION
Manufacturer Address9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-14

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