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

Model Number	720080-01
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this tactra penile prosthesis, experienced incomplete bending of the right cylinder and was unable to use the device effectively.During the surgical procedure, it was identified that a portion of the lateral right corpora was abnormally thin, also the right cylinder moved out of place, causing the tactra cylinder to bend at an abnormal angle.A new tactra device was implanted on the right side only.Additionally, the physician reinforced the thinned segment of the corpora using 3-0 pds suture.The left side retained the original tactra implant.No additional 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 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.The reported patient symptom of erosion and migration were found to be listed in the ifu.A risk review was completed and confirmed that the event of erosion, migration, and mechanical issue 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, the conclusion codes of caused not established and known inherent risk of device were assigned to this investigation.
Event or Problem Description
It was reported that the patient with this tactra penile prosthesis, experienced incomplete bending of the right cylinder and was unable to use the device effectively.During the surgical procedure, it was identified that a portion of the lateral right corpora was abnormally thin, also the right cylinder moved out of place, causing the tactra cylinder to bend at an abnormal angle.A new tactra device was implanted on the right side only.Additionally, the physician reinforced the thinned segment of the corpora using 3-0 pds suture.The left side retained the original tactra implant.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: 24621452
• Report Number: 2124215-2026-14752
• Device Sequence Number: 15986913
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: (01)08714729979340(17)290424(10)40194531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2026
• 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): 04/09/2026

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: 720080-01
• Device Catalogue Number: 720080-01
• Device Lot Number: 0040194531
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 04/25/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male