MAUDE Adverse Event Report: LAKE REGION MANUFACTURING 0.035" SUREGLIDE, BOX OF 5; STYLET, URETERAL

Model Number 35BX

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported a patient had a left ureteroscopy with stent for the indication of left ureteral stone (b)(6) 2020 using a sure glide guidewire and an holmium laser (the laser settings were: 800 mj and 8 hz.Joules: 263.20, pulses: 329, duration: 41 seconds).After the procedure, the patient experienced urinary urgency, frequency, and urethral pain.An unspecified time later, the patient had an ultrasound and it was found that the patient had retained a portion of the wire.The patient had another ureteroscopy procedure (b)(6) 2021 to try to retrieve the broken guidewire with no success.The patient was then booked for a lower ureteral pole stent, upper pole ureter ureteroscopy, removal of foreign body in the distal ureter of the upper pole ureter, ureteral stent in upper pole ureter and removal of stent in lower pole at the local hospital to have the device fragment removed (b)(6) 2021 which was successful.The patient had a stent placed and came back several weeks later to have the stent removed and is now doing fine.No further problems.The device fragment that was removed from the patient was sent to pathology.It measured 3.6cm x 0.1cm and came back as hydrophilic nitinol core.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.A physical evaluation of the device cannot be performed as the customer did not return the device for evaluation; therefore the root cause of the reported event could not be conclusively determined.However, based on the investigation, the potential causes could be attributed to joint strength design specification and or excessive force applied to device.As stated on the ifu (instruction for use) and as a preventive measure, the ifu provides the following warnings and cautions: do not apply excessive force to advance or withdraw the guidewire.Doing so may result in complications.If resistance is encountered, determine the cause and take remedial action before continuing.Also, when using a moveable core guidewire, do not attempt to advance, stiffen or straighten the tip of the guidewire against resistance.The legal manufacturer will continue to monitor the field performance of this device.

• Brand Name: 0.035" SUREGLIDE, BOX OF 5
• Type of Device: STYLET, URETERAL
• Manufacturer (Section D): LAKE REGION MANUFACTURING; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12014265
• MDR Text Key: 257214189
• Report Number: 3003790304-2021-00107
• Device Sequence Number: 1
• Product Code: EYA
• UDI-Device Identifier: 00821925005730
• UDI-Public: 00821925005730
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35BX
• Device Lot Number: 5968188
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HOLMIUM LASER; HOLMIUM LASER
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 58