FDA Adverse Event Malfunction Summary report: N

CLEARTRACT

MDR report key: 23811837 · Received December 15, 2025

Report

Report Number: 3014650073-2025-00002
Event Type: Malfunction
Date Received: December 15, 2025
Date of Event: March 29, 2023
Report Date: December 2, 2025
Manufacturer: SILQ TECHNOLOGIES CORPORATION
Product Code: EZL
UDI-DI: 00850041415154
PMA / PMN Number: K192034
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290350	CLEARTRACT	2-WAY 100% SILICONE 16FR X 10ML CLEARTRACT SPT CATHETER	EZL	SILQ TECHNOLOGIES CORPORATION	211610SPT	SLQ1610-012022	00850041415154

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR	Male	Required Intervention