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

Model Number	720081-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a tactra malleable penile prosthesis presented with inadequate axial rigidity and significant penile deformity upon manipulation, accompanied by pain and improper device function during use.During physical examination, the physician observed abnormal flexion of the prosthetic shaft on one side, resulting in a loss of symmetry and support.A structural issue with the device was suspected.A replacement surgery was scheduled.No further 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 of mechanical issue 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 patient symptoms of disfigurement and pain are 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 that a patient with a tactra malleable penile prosthesis presented with inadequate axial rigidity and significant penile deformity upon manipulation, accompanied by pain and improper device function during use.During physical examination, the physician observed abnormal flexion of the prosthetic shaft on one side, resulting in a loss of symmetry and support.A structural issue with the device was suspected.A replacement surgery was performed in which a new tactra malleable penile prosthesis was implanted.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 allegations of disfigurement and pain are known risks associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of cmc- known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that a patient with a tactra malleable penile prosthesis presented with inadequate axial rigidity and significant penile deformity upon manipulation, accompanied by pain and improper device function during use.During physical examination, the physician observed abnormal flexion of the prosthetic shaft on one side, resulting in a loss of symmetry and support.A structural issue with the device was suspected.A replacement surgery was scheduled.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: 23075846
• Report Number: 2124215-2025-64846
• Device Sequence Number: 19994826
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: (01)08714729979357(17)281231(10)40146560
• 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: 2024
• 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): 11/12/2025

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: 0040146560
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 10/15/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/12/2025
• Date Device Manufactured: 01/02/2024
• 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: 53 YR
• Patient Sex: Male