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

Model Number	720081-01
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this tactra device felt it was too short and noted that the distal end of the penis was floppy, making the device difficult to use.The device remains implanted, and a follow-up appointment has been scheduled.No additional information was reported.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of disfigurement is a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom of disfigurement is a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the dhr, the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.
Event or Problem Description
It was reported that the patient with this tactra device felt it was too short and noted that the distal end of the penis was floppy, making the device difficult to use.The device remains implanted, and a follow-up appointment has been scheduled.No additional information was 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23476520
• Report Number: 2124215-2025-78289
• Device Sequence Number: 16034646
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: (01)08714729979357(17)280718(10)40089998
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 0040089998
• 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: 10/11/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 07/20/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male