MAUDE Adverse Event Report: EP FLEX 0.038" HYBRID WIRE, BOX OF 5

Model Number GWH3805R

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

The reference device was returned to the service center for the physical evaluation, however, the evaluation is not complete at this time.The instruction manual contains several warnings and caution statements in an effort to prevent damage to the device."do not apply excessive force to advance or withdraw the wire.If resistance is encountered, determine the cause and take remedial action before continuing.When using a moveable core device, do not attempt to advance, stiffen or straighten the tip of the device against resistance.Do not reshape or alter the configuration of the device.Doing so may compromise the structural integrity of the device and may result in complications.Prepare and inspect the device according to the instruction manuals.Should any irregularity be observed, do not use them; contact the service center.

Event Description

Service center was informed that during the middle of an ureteroscopy with stent exchange procedure, the tip of the guide wire broke apart and was retrieved from the patient.An introducer was utilized with the guide wire.The procedure was prolonged by a few minutes.The doctor opened a new similar device and finished the procedure without any further problems.No patient injury was reported related to the incident.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results and additional information.The device returned to olympus inside a plastic sheathing/tube wrapped inside a plastic bag.The broken piece of the wire returned was in a small container inside the same plastic bag.The wire was broken on the distal end and the broken piece measures roughly 0.75" when flat.There was also a small chip on the proximal end of the black 'tubing' on the distal end of the wire.In addition, the guidewire was returned to the original equipment manufacturer for further investigation.The oem reported that the following are the likely possible causes for the reported event : as ultratrack was being retracted or as an ancillary device was being advanced, the pebax tip came in contact with another device that cut into the pebax at approximately 22mm from the distal tip.Continued relative movement in contact caused the pebax to be skived distally down to the corewire.At approximately 5mm from the distal tip, the skived pebax broke free from the corewire and separated from the ultratrack within the patient.A dhr review was performed for the subject device lot number 91802896 found no anomalies during the manufacturing process.

• Brand Name: 0.038" HYBRID WIRE, BOX OF 5
• Type of Device: HYBRID WIRE
• Manufacturer (Section D): EP FLEX; ermsim schwoltbogen 24; dettingen, 72581 72581 ; GM 72581
• MDR Report Key: 8754592
• MDR Text Key: 149940912
• Report Number: 2951238-2019-00987
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-EYA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWH3805R
• Device Lot Number: 91802896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRODUCER (UNKNOWN)