0.035" HYBRID WIRE, BOX OF 5 GWH3505R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for 0.035" HYBRID WIRE, BOX OF 5 GWH3505R manufactured by Gyrus Acmi, Inc.

Event Text Entries

[132066937] The device was not returned to olympus for evaluation. In addition, insufficient information was provided by the user facility. Multiple follow ups were made by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. The cause of the reported event cannot be determined at this time. However, the instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire: "inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc. Carefully and slowly withdraw the guidewire from the patient to avoid any damage. The tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking. If this occurs, it is recommended that any fragments of the outer coating material be removed. While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument.?
Patient Sequence No: 1, Text Type: N, H10


[132066938] Olympus was informed that during a procedure, the doctor had inserted the device into the patient? S kidney and when the doctor went to remove the device it could not be removed. The doctor had to remove the entire stent and then the device became? Unraveled?. The doctor used a second device from the same lot and the second device also failed as well. The procedure was completed using a non-olympus device. There was no injury reported. 2 of 2 devices
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2019-00317
MDR Report Key8210715
Date Received2019-01-02
Date of Report2019-05-21
Date of Event2018-12-10
Date Mfgr Received2019-04-23
Date Added to Maude2019-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name0.035" HYBRID WIRE, BOX OF 5
Generic NameGUIDE WIRE, HYBRID
Product CodeEYA
Date Received2019-01-02
Returned To Mfg2019-01-21
Model NumberGWH3505R
Lot Number91706356
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGYRUS ACMI, INC
Manufacturer AddressERMSIM SCHWOLTBOGEN 24 DETTINGEN, 72581 US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-02

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