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

Model Number	WA2ITA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while attempting to remove the itind, the suture became detached from the hub.The removal procedure was not performed under anesthesia, only a local topical gel.The procedure took roughly two hours and the patient experienced "additional trauma" to the urethra from multiple removal attempts.A cystoscope was ultimately required, in addition to grasping forceps, to remove the device.No other medical intervention was required.Following the procedure, there were no other injuries.

• Brand Name: ITIND, WITH SNARE, STERILE
• Common Device Name: WA2ITA00
• Manufacturer (Section D): MEDI-TATE, LTD; 17 haumann street; hadera, hafia 30600 00; IS 3060000
• MDR Report Key: 20493451
• Report Number: 2429304-2024-0000446
• Device Sequence Number: 19736851
• Product Code: QKA
• UDI-Device Identifier: 07290015518062
• UDI-Public: 07290015518062
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2024
• Report Date (Section F): 08/09/2024

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
• Device Lot Number: 28112022-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male