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

Model Number	720081-01
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a follow-up consultation, that the patient with a tactra malleable penile prosthesis stated that he is still unable to achieve satisfactory sexual activity.The device experienced rotation of the right rod on its own axis, which resulted in twisted penis causing pain.A replacement surgery has been scheduled.No additional patient complications were reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the dhr, the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported patient symptoms of disfigurement and pain are a known risks associated with this device type/procedure and it is noted as such as in the instructions for use.
Event or Problem Description
It was reported during a follow-up consultation, that the patient with a tactra malleable penile prosthesis stated that he is still unable to achieve satisfactory sexual activity.The device experienced rotation of the right rod on its own axis, which resulted in twisted penis causing pain.A replacement surgery has been scheduled.No additional patient complications were reported.
Event or Problem Description
It was reported during a follow-up consultation, that the patient with a tactra malleable penile prosthesis stated that he is still unable to achieve satisfactory sexual activity.The device experienced rotation of the right rod on its own axis, which resulted in twisted penis causing pain.A surgical procedure was performed to remove and replace the tactra.No additional patient complications were reported.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the dhr, the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported patient symptoms of disfigurement and pain are a known risks associated with this device type/procedure and it is noted as such as in the instructions for use.

• 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: 22800802
• Report Number: 2124215-2025-56675
• Device Sequence Number: 15665110
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: (01)08714729979357(17)290516(10)40195802
• 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
• Device Explanted 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,Followup
• Report Date (Section B): 12/29/2025

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: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0040195802
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 12/03/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/07/2025; 12/29/2025
• Date Device Manufactured: 05/17/2024
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 64 YR
• Patient Sex: Male