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

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.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Type of Device: GUIDWIRE
• 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 Key: 9350479
• MDR Text Key: 204564266
• Report Number: 2951238-2019-01193
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT-EYA
• Number of Events Reported: 1
• 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 Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: GWH3505R
• Device Lot Number: 91903485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/05/2020
• 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