ZINGER GUIDE WIRE - CRDM LVZRMS180J

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 2019-03-12 for ZINGER GUIDE WIRE - CRDM LVZRMS180J manufactured by Medtronic, Inc.

Event Text Entries

[138548252] Product event summary: the guidewire was returned and analyzed. The analysis indicated that the guidewire was damaged. The guidewire was kinked/buckled. The guidewire was unraveled. Visual analysis of the lead indicated damage during use. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[138548253] It was reported that during implant, the guidewire became stuck inside the lead and was unable to be retracted. The physician removed both the lead and guidewire and implant was attempted with a new lead as well as a new guidewire. During implant of the replacement lead, the new guidewire again became stuck in the lead, however the guidewire was eventually able to be retracted. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220452-2019-00022
MDR Report Key8412741
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-12
Date of Report2019-03-12
Date of Event2018-01-11
Date Mfgr Received2019-02-27
Device Manufacturer Date2015-06-04
Date Added to Maude2019-03-12
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 Received2019-03-12
Returned To Mfg2018-01-19
Model NumberLVZRMS180J
Catalog NumberLVZRMS180J
Lot NumberG15A05727
Device Expiration Date2018-06-03
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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 2019-03-12

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