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

Model Number GWH3505R

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to the olympus (b)(4) and is pending evaluation.The cause of the reported event cannot be determined at this time.If additional information becomes available following device evaluation and investigation, a supplemental report will be filed.

Event Description

The service center was informed that during an ureteroscopy (urs) procedure, the hydrophilic tip of the device broken into pieces inside the patient¿s ureter.The guidewire was withdrawn and the surgeon observed a couple of metal wires that were visible at the tip.An additional procedure was scheduled to remove the device fragments.An x-ray was performed to locate the tip; however, the surgeon was unable to retrieve the device fragments.The user facility reported that the device fragments are draining through a stent and only a 3mm fragment was left, which is expected to come out in 2 weeks.It is unknown if the initial intended procedure was completed.The patient is reportedly in good condition.Additionally, the user facility reported no metal torque device was used with this guidewire.The thumb advance introducer was used with the guidewire.The guidewire did not come in contact with a metal tip of any of the other instruments used during the procedure.No excessive force was required to withdraw or introduce the guidewire.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.The customer returned a gwh3505r for evaluation.The device was received in the plastic protective tubing.It was confirmed that the distal end of the device was not returned; the distal end had roughly 2 inches of exposed wire showing.It was also noticed that part of the blue coating on the sheath was rubbing off in a few spots.

Manufacturer Narrative

The oem performed a photographic investigation.Based on the defect pictures epflex has come to the following conclusion: the strong detachment of the coating clearly shows that the guide wire was pulled over an edge with a high force.This also caused the polymer tip to detach from the wire.The damage to the product is therefore definitely due to a user error.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Type of Device: 0.035" HYBRID WIRE
• Manufacturer (Section D): GYRUS ACMI, INC; ermsim schwoltbogen 24; dettingen, 72581 72581 ; GM 72581
• MDR Report Key: 9207786
• MDR Text Key: 163766543
• Report Number: 2951238-2019-01158
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWH3505R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention