SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303

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 2020-02-06 for SPECTRANETICS 16F GLIDELIGHT LASER SHEATH 500-303 manufactured by The Spectranetics Corporation.

Event Text Entries

[178015255] Patient's date of birth unavailable. Patient's weight unavailable.
Patient Sequence No: 1, Text Type: N, H10


[178015257] A lead extraction procedure commenced to remove one right ventricular (rv) lead due to recall. A right atrial (ra) and left ventricular (lv) lead were present in the patient and not targeted for extraction. During use of a spectranetics glidelight laser sheath among other tools, a tear to the superior vena cava/right atrial junction (svc/ra junction) was identified and successfully repaired via sternotomy. The patient survived the procedure. There was no alleged malfunction of any spectranetics device being used in the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721279-2020-00026
MDR Report Key9677815
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-06
Date of Report2020-01-10
Date of Event2020-01-10
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-01-10
Date Added to Maude2020-02-06
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 16F GLIDELIGHT LASER SHEATH
Generic NameGLIDELIGHT
Product CodeMFA
Date Received2020-02-06
Model Number500-303
Catalog Number500-303
Lot NumberFGC19J20A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 Received2020-02-06
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2020-02-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.