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

Model Number	720081-01
Medical Device Problem Codes	Fracture (1260); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this tactra had a single cylinder fractured at the site where it was attached to the ischiopubic ramus with bone anchors.A surgical procedure was performed in which the cylinder was removed and replaced with a new tactra cylinder.There were no further patient complications 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 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.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that this tactra had a single cylinder fractured at the site where it was attached to the ischiopubic ramus with bone anchors.A surgical procedure was performed in which the cylinder was removed and replaced with a new tactra cylinder.There were no further patient complications reported.
Event or Problem Description
It was reported that this tactra had a single cylinder fractured at the site where it was attached to the ischiopubic ramus with bone anchors.A surgical procedure was performed in which the cylinder was removed and replaced with a new tactra cylinder.There were no further patient complications reported.
Additional Manufacturer Narrative
Correction to b1: adverse event/product problem.Upon receipt at our quality assurance laboratory, this tactra malleable penile prosthesis underwent a thorough analysis.Microscopic inspection revealed that the cylinder had a fracture above the 16cm mark at the proximal end of the cylinder body.The cylinder was cut at 19.5cm and had several holes and cuts from sharp instrument damage between the 19.5cm and 16cm markings.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.A risk review was completed and confirmed that the event of "mechanical malfunction (fracture of the prosthesis or breach of the outer silicone layer)" was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, the sharp instrument damage identified in the cylinder could have caused or contributed to the reported clinical observation of a fracture, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 23605534
• Report Number: 2124215-2025-83986
• Device Sequence Number: 9841258
• Product Code: FAE
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2026

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: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0040250154
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 01/30/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/29/2025; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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: 28 YR
• Patient Sex: Unknown