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

Model Number	720080-01
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this tactra device presented with curvature of the penile shaft and loss of axial rigidity of the device; therefore, a replacement surgery was scheduled.No additional patient complications were reported.
Additional Manufacturer Narrative
Corrected b1: adverse event/product problem.Additional information updated: h6: evaluation conclusion codes.
Event or Problem Description
It was reported that the patient with this tactra device presented with curvature of the penile shaft and loss of axial rigidity of the device; therefore, a replacement surgery was scheduled.No additional patient complications were reported.

• 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: 22019368
• Report Number: 2124215-2025-30591
• Device Sequence Number: 13123369
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: (01)08714729979340(17)260902(10)28017262
• 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: 2023
• 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): 06/02/2025

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 Expiration Date: 09/02/2026
• Device Model Number: 720080-01
• Device Catalogue Number: 720080-01
• Device Lot Number: 0028017262
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 09/03/2021
• 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: 70 YR
• Patient Sex: Male