ZINGER GUIDE WIRE - CRDM LVZRXT180S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-09 for ZINGER GUIDE WIRE - CRDM LVZRXT180S manufactured by Medtronic, Inc.

Event Text Entries

[38331730] This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[38331731] It was reported that during use with left ventricular (lv) lead, the guide wire was destroyed. The guide wire was removed and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[42295227] Product event summary: the device was returned and analyzed. Analysis revealed the stylet/guidewire was kinked/buckled, the guidewire was unraveled.
Patient Sequence No: 1, Text Type: N, H10


[47405768] Product event summary: additional analysis of the returned guidewire noted damage during use. Analysis revealed the stylet/guidewire was broken, the stylet/guidewire was kinked/buckled, the guidewire was unraveled. Additional analysis of the returned guide wire noted one lv zinger guide wire with no original packaging. As received the wire was coil wrapped in a pouch. The wire is stretched and missing the distal tip. From the proximal end of the wire to the distal end of the core wire measures approximately 176cm indicating approximately 2cm of the wire is missing including the distal bond joint, solder tip and ribbon. The blood was cleaned from end of wire with warm water. The broke end of the coil is visible. The break occurred on the proximal side of the distal bond joint. Proximal bond shows coil stretched in a distal direction. It appears the wire was torqued beyond the design requirements. No manufacturing root cause identified. The detached tip of the wire was not returned.
Patient Sequence No: 1, Text Type: N, H10


[101875925] 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 Number1220452-2016-00004
MDR Report Key5422059
Date Received2016-02-09
Date of Report2015-12-09
Date of Event2015-12-09
Date Mfgr Received2016-04-22
Device Manufacturer Date2015-01-12
Date Added to Maude2016-02-09
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 CARDIAC RHYTHM HEART FAILURE
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZINGER GUIDE WIRE - CRDM
Generic NameOCCLUDER, CATHETER TIP
Product CodeDQT
Date Received2016-02-09
Returned To Mfg2015-12-22
Model NumberLVZRXT180S
Catalog NumberLVZRXT180S
Lot NumberG15A00318
Device Expiration Date2018-01-11
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 2016-02-09

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