MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TACTRA; PROSTHESIS PENILE

Model Number	720082-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fluid Discharge (2686); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with a tactra device presented with fluid discharge.A replacement surgery has been requested.No additional information was provided.
Additional Manufacturer Narrative
Correction to field b2: outcomes attrib to adv event.Correction to field b5: describe event or problem.Correction to field h6: patient codes.The device is not available for analysis; therefore, no physical analysis of the product could be performed.There was no report of a device performance allegation.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.With all the information available, boston scientific concludes that there is no information to reasonably suggest that this type of event or its recurrence could cause or contribute to death, serious injury or serious deterioration in the state of health of a patient, user, or other person, and the medical/surgical intervention requested is not to prevent patient harm.Therefore, the event does not meet reporting criteria definitions.
Event or Problem Description
It was reported that the patient with a tactra device presented with a non-functional artificial urinary sphincter (aus).A replacement surgery was requested.No device issues were reported with the tactra.No additional information was provided.

• Brand Name: TACTRA
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23377673
• Report Number: 2124215-2025-74947
• Device Sequence Number: 8964873
• Product Code: FAE
• UDI-Device Identifier: 08714729979364
• UDI-Public: (01)08714729979364(17)281231(10)40163369
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K183619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 720082-01
• Device Catalogue Number: 720082-01
• Device Lot Number: 0040163369
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• 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 Age: 73 YR
• Patient Sex: Male