MAUDE Adverse Event Report: BIOPROTECT LTD. BIOPROTECT BALLOON IMPLANT SYSTEM

Model Number	5135
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to bioprotect ltd.That a bioprotect balloon implantation procedure was performed on (b)(6) 2026.During planning ct on (b)(6) 2026 it was found that the balloon appearance on ct was not as expected.A discussion with the physician revealed that the balloon was intentionally filled with contrast media rather than saline as specified in the product's instructions for use (also emphasized during physician's training).The patient underwent an additional procedure where the contrast media was removed from the balloon and replaced with saline.The investigation findings suggest that the root cause of the event is related to abnormal use rather than to a device-related issue.The patient did not present any clinical symptoms, and his radiation treatment was delayed for approximately 1 month.

• Brand Name: BIOPROTECT BALLOON IMPLANT SYSTEM
• Common Device Name: BIOPROTECT BALLOON IMPLANT SYSTEM
• Manufacturer (Section D): BIOPROTECT LTD.; 6 ha'gavish st; netanya, 42507 06,; IS 4250706,
• Manufacturer (Section G): BIOPROTECT LTD; 6 ha'gavish st.; netanya, 42507 06; IS 4250706
• Manufacturer Contact: noga avisar ; 6 ha'gavish st.; netanya, 42507-06 ; IS 4250706
• MDR Report Key: 25688861
• Report Number: 3014285231-2026-00013
• Device Sequence Number: 9731134
• Product Code: OVB
• UDI-Device Identifier: 07290014878020
• UDI-Public: (01)07290014878020(11)250505(17)270504
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K222972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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
• Device Model Number: 5135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male