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	Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this tactra malleable penile prosthesis experienced paraphimosis with moderate edema of the foreskin; therefore, through a non-surgical intervention, the tissue was repositioned to its normal location and the event was resolved.No additional patient complications were reported.
Additional Manufacturer Narrative
Corrected h6: patient codes.
Event or Problem Description
It was reported that the patient with this tactra malleable penile prosthesis experienced paraphimosis with moderate edema of the foreskin; therefore, through a non-surgical intervention, the tissue was repositioned to its normal location and the event was resolved.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: 21410483
• Report Number: 2124215-2025-09712
• Device Sequence Number: 12841267
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: 08714729979340
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K183619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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 Model Number: 720080-01
• Device Catalogue Number: 720080-01
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/25/2025
• 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
• Patient Sex: Male