MAUDE Adverse Event Report: BENDIT 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	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to manufacturer for evaluation.No finding related to manufacturing.
Event or Problem Description
Young female with a right superior hypopheseal segment aneurysm.Access via radial approach using a rist catheter.When trying to navigate the aneurysm from cavernous to sup hyp, lack of response on advancing or pulling back the device was felt.When the whole system was retrieved, a fracture was noted.

• Brand Name: BENDIT21 MICROCATHETER
• Common Device Name: BENDIT21 MICROCATHETER
• Manufacturer (Section D): BENDIT TECHNOLOGIES LTD.; 25 basel st.; petach tikva, 49510 38; IS 4951038
• Manufacturer (Section G): BENDIT TECHNOLOGIES LTD.; 25 basel; petach tikva, 49510 38; IS 4951038
• Manufacturer Contact: simona beilin ; 25 basel; petach tikva, 49510-38 ; IS 4951038
• MDR Report Key: 19757149
• Report Number: 3017278832-2024-00001
• Device Sequence Number: 15707349
• Product Code: QJP
• UDI-Device Identifier: 17290018072049
• UDI-Public: (01)17290018072049
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

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: 01/17/2025
• Device Model Number: BDT21157U2
• Device Lot Number: 230503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female