ZINGER GUIDE WIRE - CRDM LVZRXT180J

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-12-07 for ZINGER GUIDE WIRE - CRDM LVZRXT180J manufactured by Medtronic, Inc.

Event Text Entries

[94494151]
Patient Sequence No: 1, Text Type: N, H10


[94494152] It was reported that during the implant, after placing the lead in the target vein, the physician was using the support guidewire with the lead and when pulling the guidewire back, it got stuck in the vessel, which was very thin. With the retraction movement, the guidewire stretched and broke into two pieces; one part remained inside the lead and also out of the distal part of the lead, in the vein. The other piece was still in the physician's hand. The physician decided to leave the lead with the guidewire in place and removed the rest of the delivery system. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220452-2017-00126
MDR Report Key7090986
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-12-07
Date of Report2019-03-01
Date of Event2017-10-25
Date Mfgr Received2019-02-27
Device Manufacturer Date2015-04-10
Date Added to Maude2017-12-07
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 ContactLISA ROBERTSON
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635262723
Manufacturer G1MEDTRONIC, INC
Manufacturer Street37A CHERRY HILL DR
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal Code01923
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZINGER GUIDE WIRE - CRDM
Generic NameOCCLUDER, CATHETER TIP
Product CodeDQT
Date Received2017-12-07
Returned To Mfg2017-11-08
Model NumberLVZRXT180J
Catalog NumberLVZRXT180J
Lot NumberG15A02720
Device Expiration Date2018-04-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC
Manufacturer Address37A CHERRY HILL DR DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-07

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