GUIDEZILLA II 1871

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-26 for GUIDEZILLA II 1871 manufactured by Boston Scientific Corporation.

Event Text Entries

[185046387] It was reported that the tip of the guidezilla damages another device. The 80% stenosed target lesion was located in the severely tortuous and moderately calcified right coronary artery. A 6f guidezilla ii was selected for use with a synergy stent. The synergy stent could not cross the lesion due to angulation. Upon stent removal, it was noted that the proximal end of the stent edge was caught at the tip of the guidezilla. Subsequently, resistance of the stent was felt when it was push and pulled back the stent. The synergy, guidezilla ii and guidewire were removed together. It was observed that the synergy stent was deformed. The procedure was completed with another device. No patient complications were reported and patient status was good.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03833
MDR Report Key9883585
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-18
Date Mfgr Received2020-03-18
Device Manufacturer Date2019-10-10
Date Added to Maude2020-03-26
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC SCIMED, INC
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal Code55311
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGUIDEZILLA II
Generic NameCATHETER, PERCUTANEOUS
Product CodeDQY
Date Received2020-03-26
Model Number1871
Catalog Number1871
Lot Number0024579901
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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