MAUDE Adverse Event Report: SILQ TECHNOLOGIES CORPORATION CLEARTRACT; 2-WAY 100% SILICONE 16FR X 10ML CLEARTRACT SPT CATHETER

Model Number	211610SPT
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immediately upon notification of the event, silq received the device in question, although no issue with the device could be identified.Catheter was successfully replaced with a new device without issue.The analysis of the device was unable to establish if the event was caused by an issue with the device or was caused by the specific conditions of the patient's bladder, such as presence of bladder stones.
Event or Problem Description
On (b)(6) 2023, a patient participating in a clinical study underwent implantation of a silq cleartract catheter.The same day, the site received a call from the patient stating that the catheter was not working (in retention).The patient also reported abdominal pain and constipation.On (b)(6) 2023, the patient returned to the clinic; catheter blockage was observed and the catheter was removed.The event was considered resolved upon catheter explant.The catheter in question was returned to silq and was evaluated by silq representatives.

• Brand Name: CLEARTRACT
• Common Device Name: 2-WAY 100% SILICONE 16FR X 10ML CLEARTRACT SPT CATHETER
• Manufacturer (Section D): SILQ TECHNOLOGIES CORPORATION; 323 sunny isles blvd; fl 7; sunny isles beach CA 33160
• Manufacturer (Section G): PATHWAY MEDTECH; 8779 cottonwood ave; unit# 105; santee CA 92071
• Manufacturer Contact: ethan rao ; 323 sunny isles blvd; fl 7; sunny isles beach 33160 ; 4243098523
• MDR Report Key: 23811837
• Report Number: 3014650073-2025-00002
• Device Sequence Number: 9359786
• Product Code: EZL
• UDI-Device Identifier: 00850041415154
• UDI-Public: 00850041415154
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K192034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2025
• Device Model Number: 211610SPT
• Device Catalogue Number: 211610SPT
• Device Lot Number: SLQ1610-012022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2023
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male