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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5 GUIDWIRE

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GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5 GUIDWIRE Back to Search Results
Model Number GWH3505R
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2019
Event Type  malfunction  
Manufacturer Narrative
The device evaluation has not been completed as the device will be sent to the oem for investigation. If additional information becomes available following device evaluation, a supplemental report will be filed. The review of the dhr of lot number 91902066 and 91902067 by the oem showed that the production has been done according to the valid specifications. All process steps and all inspections have been done as prescribed.
 
Event Description
The customer reported that the product (ultratrack guidewire model name: gwh3505r) malfunctioned while in use on a patient for a rirs (retrograde intrarenal surgery). After removing the kidney stone during the procedure, the user tried to insert stent through ultratrack guidewire. The stent was not inserted smoothly and it seemed to be caught. The user took out the guidewire from the patient body and found out the core wire was sticking out from the blue coating (ptfe sleeve) at the end of the guidewire. As the device was abnormal, the procedure was terminated with a replacement of the same set of equipment.
 
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Brand Name0.035" HYBRID WIRE, BOX OF 5
Type of DeviceGUIDWIRE
Manufacturer (Section D)
GYRUS ACMI, INC
ermsim schwoltbogen 24
dettingen, 72581 72581
GM 72581
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key9350479
MDR Text Key204564266
Report Number2951238-2019-01193
Device Sequence Number1
Product Code EYA
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
EXEMPT-EYA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGWH3505R
Device Lot Number91903485
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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