SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH 560-009

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-17 for SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH 560-009 manufactured by The Spectranetics Corporation.

MAUDE Entry Details

Report Number1721279-2020-00016
MDR Report Key9604392
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-17
Date of Report2019-12-23
Date of Event2019-12-23
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2019-12-23
Date Added to Maude2020-01-17
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 Sequence Number: 1

Brand NameSPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH
Generic NameTIGHTRAIL
Product CodeDRE
Date Received2020-01-17
Returned To Mfg2020-01-10
Model Number560-009
Catalog Number560-009
Lot NumberFRN19K22A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerTHE SPECTRANETICS CORPORATION
Manufacturer Address9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921

Device Sequence Number: 101

Product Code---
Date Received2020-01-17
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-17

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