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,health report with the FDA on 2018-05-01 for ZINGER GUIDE WIRE - CRDM LVZRMS180J manufactured by Medtronic, Inc.

Event Text Entries

[107008526] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[107008527] It was reported that during the implant procedure, the guidewire unraveled. The physician stated there was never any sticking of the guidewire in the left ventricular (lv) lead and the physician pulled back the guidewire and the wire had fallen apart with many thin wispy like pieces everywhere. The distal portion of the wire was still externalized at the lead tip and came back with the lead both times. The lead and the guidewire were removed and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[107444041] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[118544777] Product event summary: the guidewire was returned and engaged in the lead. The distal tip of the wire was still attached by the coil and the wire was stretched from the proximal bond joint forward. The distal bond joint was pulled apart breaking the core wire on the proximal side of the joint; the wire was badly damage. There was a kink in the distal tip behind the solder joint. Distal end of broke core wire. There appeared to be a surface imperfection at the break site and the proximal bond joint was stretched indicating pull force. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[118545077] Product event summary: the wire was engaged in the lead. The distal tip of the wire was still attached by the coil. The wire was stretched from the proximal bond joint forward. The distal bond joint was pulled apart breaking the core wire on the proximal side of the joint. The wire was damaged. None of the wire was missing and the distal tip of wire was s shaped. There was a kink in the distal tip behind the solder joint. Distal end of broke core wire. There appeared to be a surface imperfection at the break site. The proximal bond joint was stretched indicating pull force. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1220452-2018-00040
MDR Report Key7476406
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-05-01
Date of Report2018-10-02
Date of Event2018-04-03
Date Mfgr Received2018-08-08
Device Manufacturer Date2015-08-26
Date Added to Maude2018-05-01
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 ContactANNE SCHILLING
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635052036
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 Received2018-05-01
Returned To Mfg2018-04-20
Model NumberLVZRMS180J
Catalog NumberLVZRMS180J
Lot NumberG15A07657
Device Expiration Date2018-08-25
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
142981. Life Threatening 2018-05-01

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