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	Internal Organ Perforation (1987)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject device was deployed blindly in the patient's bladder through a rigid cystoscope sheath during an unspecified therapeutic procedure.The device slightly punctured the bladder causing a small perforation.There was no intraperitoneal injury, so the doctor decided to place the device while leaving a catheter to assist in voiding and healing.The patient since had the device removed and was stated to be doing fine.The doctor plans on scoping the patient in 3 months for follow up.

• 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: 20392606
• Report Number: 2429304-2024-0000434
• Device Sequence Number: 7944528
• Product Code: KOE
• UDI-Device Identifier: 07290015518062
• UDI-Public: 07290015518062
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/07/2024
• Report Date (Section F): 09/16/2024

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: 27102022-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/16/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• 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: Unknown