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	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.No findings related to manufacturing.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
Patient with a giant cavernous sinus aneurysm.Radial access with the bendit21 microcatheter was employed to reach the aneurysm.During the access attempt, the catheter broke and while removing a distal section of the catheter remained within the forearm and was removed using a snare.The bendit21 microcatheter is intended for femoral access, the risk profile of using the device in radial access is not known.The physician transferred to femoral access and used a second bendit21 catheter which succeeded to obtain access to the aneurysm and enable further treatment of 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: 18182213
• Report Number: 3017278832-2023-00002
• Device Sequence Number: 12734994
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2023

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: 05/05/2023
• Initial Report FDA Received Date: 11/21/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female