MAUDE Adverse Event Report: MEDI-TATE LTD. iTind, with snare, sterile; WA2ITA00

Model Number	WA2ITA00
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from the physician, a 13/15 fr access sheath had been planned for the removal procedure; however, only a 12/14 fr sheath was available.During the office removal procedure, the device could not be retrieved using the available sheath.Assistance was requested from two experienced physicians.During a subsequent retrieval attempt, the device suture broke near the tip of the penis.An attempt to attach an additional suture was unsuccessful.The patient was admitted to the hospital and underwent operative retrieval under general anesthesia the following day.The urethral stricture was dilated to allow insertion of a rigid 19 fr cystoscope.The remaining suture was captured using a basket and threaded through the cystoscope; however, the suture broke again during withdrawal.According to the physician, the device had been pulled into the cystoscope but significant resistance was encountered.Ultrasound examination reportedly demonstrated that the device had engaged a portion of the bladder wall.The device was released back into the bladder and was subsequently removed intact using alternative endoscopic instruments through the 19 fr cystoscope.No device components remained in the patient.

• 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: 50056816
• Report Number: 2429304-2026-00103
• Device Sequence Number: 9211442
• Product Code: QKA
• UDI-Device Identifier: 07290015518062
• UDI-Public: 07290015518062
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026
• Report Date (Section F): 07/28/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/07/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2026
• 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; Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 07/28/2026