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

Model Number	720080-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/17/2025
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 symptom of pain 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.
Event or Problem Description
It was reported that the patient with this tactra implant experienced pain during intercourse due to significant tortuousness of the device toward the left side.Upon physical examination, the prosthesis demonstrated marked curvature to the left and did not remain erect, even when manual contralateral support was attempted.The device exhibited mechanical issues but remains implanted.A surgical intervention is planned.No further patient complications were 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 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 symptom of pain is a known risk associated with implant of these device as indicated in the instructions for use (ifu).
Event or Problem Description
It was reported that the patient with this tactra implant experienced pain during intercourse due to significant tortuousness of the device toward the left side.Upon physical examination, the prosthesis demonstrated marked curvature to the left and did not remain erect, even when manual contralateral support was attempted.The device exhibited mechanical issues but remains implanted.A surgical intervention is planned.No further patient complications were 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 device performance allegation cannot be confirmed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The reported patient symptom of pain is a known risk associated with implant of these device as indicated in the instructions for use (ifu).
Event or Problem Description
It was reported that the patient with this tactra implant experienced pain during intercourse due to significant tortuousness of the device toward the left side.Upon physical examination, the prosthesis demonstrated marked curvature to the left and did not remain erect, even when manual contralateral support was attempted.The device exhibited mechanical issues.As a result, the device was explanted and replaced.No further 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: 23266735
• Report Number: 2124215-2025-71184
• Device Sequence Number: 5178871
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: (01)08714729979340(17)260908(10)28021790
• 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: 2022
• Device Explanted Year: 2026
• 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): 02/24/2026

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: 09/08/2026
• Device Model Number: 720080-01
• Device Catalogue Number: 720080-01
• Device Lot Number: 0028021790
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 01/30/2026
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/13/2025; 02/24/2026
• Date Device Manufactured: 09/09/2021
• 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; Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male