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

Model Number	720082-01
Medical Device Problem Codes	Defective Device (2588); Malposition of Device (2616)
Health Effect - Clinical Codes	Discomfort (2330); Deformity/ Disfigurement (2360)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this tactra device experienced penile deformity and discomfort, attributed to excessive curvature of the device.The physician suspects that this curvature may be due to the nitinol's memory properties.In addition, it was noted that the device was mispositioned.A surgical procedure was performed to remove the tactra and no additional 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: 20893748
• Report Number: 2124215-2024-77966
• Device Sequence Number: 15429371
• Product Code: FAE
• UDI-Device Identifier: 08714729979364
• UDI-Public: 08714729979364
• 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: 2024
• 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
• Report Date (Section B): 12/10/2024

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: 720082-01
• Device Catalogue Number: 720082-01
• 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: 11/20/2024
• Initial Report FDA Received Date: 12/10/2024
• 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
• Patient Age: 80 YR
• Patient Sex: Male