MAUDE Adverse Event Report: MEDI-TATE LTD. ITIND; ITIND SYSTEM

Model Number	MT-FA04
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per the reported description, the ifu was not followed and a user error occurred when the suture was released prior to the positioning of the itind.The removal of the itind was unsuccessful probably due to the inexperience of the doctor (second procedure) and the fact that he didn't agree to use the cystoscope optics, thus trying to pull the device into the cystoscope blindly.He then decided to switch to a turp procedure, at the end of which removal as per itind ifu was performed (grasper).The decision of the doctor to switch to a turp for treatment of the bph resulted in hospitalization not planned as the itind procedure does not require the patient to be hospitalized, but a turp, as standard, does.However, this cannot be attributed to the itind itself.Although the device did not malfunction and there was no injury to the patient, a surgical intervention was necessary to perform the removal of the itind as outlined in the ifu and to avoid a potential injury.
Event or Problem Description
On (b)(6) 2021 2 procedures were performed at (b)(6) hospital, (b)(6).The first one held at 08:45 in the morning went on without any problems or complications.In the second procedure, after the passage of the itind device inside the cystoscopy shirt, by mistake in the steps of the procedure, the itind suture was accidentally pulled and it was released from its tube guide, this step should be done only after the final positioning of the itind in the prostate, because after loosening the suture, the device's maneuverability control is lost.Therefore, it was recommended that the team remove the device to apply another unit.When performing the removal using the cystoscopy sheet, the suture broke from the itind and it was released inside the patient's bladder.To remove the device, it was necessary to introduce a 24 fr sheet for prostate resection, the procedure was converted to a monopolar prostate trp (transurethral resection of the prostate).Where the obstructive tissue was removed, and with better flow and better visualization, the itind device was completely removed with the aid of an optical grasping forceps.

• Brand Name: ITIND
• Common Device Name: ITIND SYSTEM
• Manufacturer (Section D): MEDI-TATE LTD.; 17 hauman street; hadera, 38501 69; IS 3850169
• MDR Report Key: 11853799
• Report Number: 3016677053-2021-00001
• Device Sequence Number: 14544585
• Product Code: QKA
• UDI-Device Identifier: 07290015518062
• UDI-Public: 07290015518062
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: DEN190020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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 Expiration Date: 06/14/2022
• Device Model Number: MT-FA04
• Device Catalogue Number: MT-FA04
• Device Lot Number: U1S14062020-1
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/20/2021
• 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 Age: 63 YR