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	Material Rupture (1546)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immediately upon notification of the event, silq received the device in question and verified that the catheter balloon did rupture.Catheter was successfully replaced with a new device without issue.The analysis of the returned 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.Silq has continued to monitor all product complaints for recurrence of this issue and is not aware of any subsequent instances.
Event or Problem Description
A patient participating in a clinical study (b)(6) was provided a 2-way 100% silicone, 16fr x 10ml, cleartract spt catheter (primary di: (b)(4)).The catheter was inserted with no apparent issues by a nurse at (b)(6) on (b)(6) 2023.On (b)(6) 2023, the patient returned complaining of pain and discomfort.The attending nurse tried to deflate the balloon to check the positioning of the catheter and the balloon did not have any water in it.The nurse tried to add water to the balloon, however, all of the water from the balloon ran immediately out of the urethra along the catheter.The nurse then removed the catheter and replaced with a non-study catheter.Upon removal of the silq catheter, the nurse noted that the balloon was ruptured.(b)(6), (b)(6) coordinator, reported the event to silq technologies.Silq technologies made contact with the nurse and physician who indicated that there was no injury to the patient and no pain associated directly with the catheter.A silq employee visited the facility on (b)(6) 2023 to retrieve the catheter.Further analysis confirmed the catheter balloon had ruptured, although a root cause of the rupture could not be established.

• 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; 7th floor; sunny isles beach FL 33160
• Manufacturer (Section G): PATHWAY MEDTECH; 8779 cottonwood ave; unit #105; santee CA 92071
• Manufacturer Contact: ethan rao ; 323 sunny isles blvd; sunny isles beach, FL 33160 ; 4243098523
• MDR Report Key: 23811813
• Report Number: 3014650073-2025-00001
• Device Sequence Number: 13108718
• Product Code: EZL
• UDI-Device Identifier: 00850041415154
• UDI-Public: 00850041415154
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2025
• Device Model Number: 211610SPT
• Device Catalogue Number: 211610SPT
• Device Lot Number: SLQ1610-012022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• 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: 80 YR
• Patient Sex: Unknown