MAUDE Adverse Event Report: MEDI-TATE LTD. ITIND, WITH SNARE, STERILE; WA2ITA00

Model Number	WA2ITA00
Medical Device Problem Codes	Defective Component (2292); Migration (4003)
Health Effect - Clinical Codes	Urinary Frequency / Polyuria (2275); Urinary Incontinence (4572)
Date of Event	11/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the following day after a bph (benign prostatic hyperplasia) treatment procedure, the patient complained of excessive leaking of urine.It was found out that this implantable subject device had migrated.A medical intervention was done to anchor the subject device again with no success.The subject device was removed, and it was found the anchoring leaf seemed defective.The procedure was successfully completed with an olympus back up device.There were no further reports of patient harm.

• Brand Name: ITIND, WITH SNARE, STERILE
• Common Device Name: WA2ITA00
• Manufacturer (Section D): MEDI-TATE LTD.; 17 hauman street; hadera 38501 69; IS 3850169
• MDR Report Key: 21044404
• Report Number: 2429304-2024-01063
• Device Sequence Number: 18251108
• Product Code: QKA
• UDI-Device Identifier: 07290015518062
• UDI-Public: 07290015518062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2024
• Report Date (Section F): 12/30/2024

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/03/2024
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/30/2024