MAUDE Adverse Event Report: MEDI-TATE LTD. ITIND, WITH SNARE, STERILE; WA2ITA0R

Model Number	WA2ITA00
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Sepsis (2067); Urinary Tract Infection (2120)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported after removal of an itind, on an unspecified date, the patient acquired a urinary tract infection and was subsequently admitted to the hospital for sepsis.It was noted that the removal of the itind did not go ideally as the device did not come fully into the removal catheter.There were no further reports of patient harm.Despite multiple attempts for additional information, none was obtained.This report is linked to the following patient identifier: (b)(6).

• Brand Name: ITIND, WITH SNARE, STERILE
• Common Device Name: WA2ITA0R
• Manufacturer (Section D): MEDI-TATE LTD.; 17 hauman street; hadera 38501 69; IS 3850169
• MDR Report Key: 21691538
• Report Number: 2429304-2025-00106
• Device Sequence Number: 18309693
• Product Code: QKA
• UDI-Device Identifier: 07290015518062
• UDI-Public: 07290015518062
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2025
• Report Date (Section F): 03/25/2025

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 Model Number: WA2ITA00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WA2ITA00
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 03/25/2025