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

Model Number	720082-01
Medical Device Problem Codes	Nonstandard Device (1420); Migration (4003)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a tactra malleable device underwent replacement surgery due to dissatisfaction, stating that they did not like the device being rigid at all times.During the revision procedure, the physician confirmed distal crossover from the prior implantation.The entire device was explanted and replaced with a three piece inflatable device.The physician stated being extremely cautious when placing the cylinders and ensuring they remained in their respective spaces.No further patient complications were reported.
Additional Manufacturer Narrative
The device was not available for analysis; therefore, no physical evaluation could be performed.As a result, the reported device performance allegation of device operates differently than expected cannot be confirmed.Tissue damage and cylinder migration are acknowledged within the dfu and are not associated with off-label use or failure to follow instructions.Additionally, based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment, indicating that manufacturing was not related to the reported event.Without the returned product for analysis and based on this investigation, a clear probable cause for the event cannot be established.Therefore, the conclusion code cause not established has been selected.
Event or Problem Description
It was reported that a patient with a tactra malleable device underwent replacement surgery due to dissatisfaction, stating that they did not like the device being rigid at all times.During the revision procedure, the physician confirmed distal crossover from the prior implantation.The entire device was explanted and replaced with a three-piece inflatable device.The physician stated being extremely cautious when placing the cylinders and ensuring they remained in their respective spaces.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: 23751529
• Report Number: 2124215-2025-87079
• Device Sequence Number: 14925732
• Product Code: FAE
• UDI-Device Identifier: 08714729979364
• UDI-Public: (01)08714729979364(17)271012(10)30404361
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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 Model Number: 720082-01
• Device Catalogue Number: 720082-01
• Device Lot Number: 0030404361
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 10/13/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male