SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER 590-001

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 2020-02-18 for SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER 590-001 manufactured by The Spectranetics Corporation.

MAUDE Entry Details

Report Number1721279-2020-00036
MDR Report Key9723259
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-18
Date of Report2020-01-21
Date of Event2020-01-21
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2020-01-21
Date Added to Maude2020-02-18
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 BRIDGE OCCLUDING BALLOON CATHETER
Generic NameBRIDGE
Product CodeMJN
Date Received2020-02-18
Model Number590-001
Catalog Number590-001
Lot NumberUNAVAILABLE FROM FACILITY
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 Received2020-02-18
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-18

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