MAUDE Adverse Event Report: BEND IT TECHNOLOGIES LTD. BENDIT21 MICROCATHETER

Model Number	BDT21157U2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bendit believed it had successfully initiated a web trader account and completed submitting all requisite test data prior to timely filing this 3500a.Unfortunately, the company recently recognized that this was not the case.As a result, this event is being filed retrospectively.
Event or Problem Description
The bendit21 microcatheter was used to access the aca aneurysm aneurysm in patient with highly tortuous blood vessel anatomy.Due to the extremely high tortuosity a significant articulation and torquing forces were applied to the catheter resulting in catheter breakage.Catheter was removed with no harm to the patient.

• Brand Name: BENDIT21 MICROCATHETER
• Common Device Name: BENDIT21 MICROCATHETER
• Manufacturer (Section D): BEND IT TECHNOLOGIES LTD.; 25 basel st.; petach tikva, 49510 38; IS 4951038
• Manufacturer (Section G): BEND IT TECHNOLOGIES LTD.; 25 basel st.; petach tikva, 49510 38; IS 4951038
• Manufacturer Contact: simona beilin nissan ; 25 basel st.; petach tikva, 49510-38 ; IS 4951038
• MDR Report Key: 18178687
• Report Number: 3017278832-2023-00001
• Device Sequence Number: 18071645
• Product Code: QJP
• UDI-Device Identifier: 17290018072049
• UDI-Public: (01)17290018072049
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2024
• Device Model Number: BDT21157U2
• Device Lot Number: 230101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female