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

Catalog Number	5135
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Retention (2119)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to bioprotect ltd.On (b)(6) 2026 that a bioprotect balloon implantation procedure was performed on (b)(6) 2026.The procedure was done under local anesthesia following placement of fiducial markers.During the procedure, multiple placement attempts were required after an initial tract extended beyond the prostatic apex and engaged the posterior capsule.The balloon was ultimately deployed in an acceptable position.Post-procedure, the patient developed urinary retention requiring foley catheter placement, which resolved within 48 hours.Planning mri (b)(6) 2026), imaging raised concern for hematoma and possible vascular injury.Subsequent dynamic contrast mri suggested a periprostatic arteriovenous fistula, and the patient underwent successful coil embolization with resolution of the vascular abnormality.The remaining pelvic vasculature was unremarkable.The patient was admitted for 24-hour observation and was reported to be fine.His radiation treatment (sbrt) has been delayed, and new planning imaging will be scheduled.

• 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: 24730457
• Report Number: 3014285231-2026-00007
• Device Sequence Number: 9269832
• Product Code: OVB
• UDI-Device Identifier: 07290014878020
• UDI-Public: (01)07290014878020(11)250608(17)270607
• 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): 03/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 5135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2026
• Initial Report FDA Received Date: 03/30/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male