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

Model Number GWH3805R

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

In troubleshooting the issue with olympus technical support via the phone, the reporter stated as a result of the issue, the facility wanted to pull the rest of three (3) un-opened 0.038" hybrid wires from inventory and return the three un-opened 0.038" hybrid wires with the used 0.038" hybrid wire.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported to olympus that during a therapeutic ureteroscopy procedure to remove a ureteral stone, the distal tip of the 0.038" hybrid wire had broken.The laser was used to break the stone, but it was in the lower third of the ureter.Fragments of the ureteral calculus were retrieved, and a stent was inserted.At the end of the case, the wire was pulled from the stent and was bound up but released and was pulled out.When the user used the c-arm to view the stent, there was foreign material in the kidney of the patient.The wire was checked, and the distal tip of the wire (half of the hydrophilic tip) had broken off and remained in the patient.The user had to pull the stent again and go back into the kidney to extract the piece that was missing from the wire.To complete the procedure, another guidewire and basket were used.There was a surgical delay of approximately fifteen (15) minutes.There was no harm to the patient other than the increased surgery time.This complaint is related to patient identifiers: (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record performed by ep flex found no deviations that could have caused or contributed to the reported issue.The device was returned and evaluated, and the phenomenon was confirmed.Based on the results of the investigation, there was a significant non-uniform tungsten distribution compared to a random finished product test lot.Surface areas of high tungsten concentration also appeared to have different surface tension or hydrophobic characteristics which resisted the flow of the hydrophilic coating.The oem observed that the tensile strength of these products no longer meet specification.However, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 0.038" HYBRID WIRE, BOX OF 5
• Type of Device: STYLET, URETERAL
• Manufacturer (Section D): EP FLEX; ermsim schwoltbogen 24; dettingen, 72581 72581 ; GM 72581
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 11761495
• MDR Text Key: 260859726
• Report Number: 3003790304-2021-00076
• Device Sequence Number: 1
• Product Code: EYA
• UDI-Device Identifier: 00821925031449
• UDI-Public: 00821925031449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-EYA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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: 91905598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2022
• 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
• Patient Sequence Number: 1