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

Model Number	720080-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
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 symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this tactra malleable penile prosthesis experienced pain and urinary symptoms, including hesitancy and post-void dribbling.The patient was brought to the operating room (or), and a scan revealed a retained rear tip from a prior non-bsc inflatable implant.The right malleable implant was explanted, and a perineal approach was used to remove the retained rear tip.A new tactra was implanted on the right side.There were no additional patient complications 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 symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this tactra malleable penile prosthesis experienced pain and urinary symptoms, including hesitancy and post-void dribbling.The patient was brought to the operating room (or), and a scan revealed a retained rear tip from a prior non-bsc inflatable implant.The physician believed that the patients pain and urinary symptoms may have been caused by the retained rear tip as well as the impact it had on the malleable device.The right malleable implant was explanted, and a perineal approach was used to remove the retained rear tip.A new tactra was implanted on the right side.There were no additional patient complications 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: 23022697
• Report Number: 2124215-2025-63197
• Device Sequence Number: 13065695
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: (01)08714729979340(17)240911(10)24464041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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): 10/31/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/11/2024
• Device Model Number: 720080-01
• Device Catalogue Number: 720080-01
• Device Lot Number: 0024464041
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/31/2025
• Date Device Manufactured: 09/13/2019
• 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 Age: 68 YR
• Patient Sex: Male