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

Model Number	720080-01
Medical Device Problem Codes	Fracture (1260); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's tactra penile prothesis, exhibited a broken cylinder.A surgical procedure was performed during which was identified that the bone anchors used to hold it in place, tore through the silicone of the cylinder.The tactra was removed and replace with an inflatable penile prosthesis (ipp).No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the tactra cylinder was visually inspected and found to be fractured at 16.0 cm, with a hole consistent with sharp instrument damage identified at the 16.5 cm mark.The cylinder was cut to 17.5 cm.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 cylinder fracture identified in the tactra cylinder could have caused or contributed to the reported clinical observation of cylinder - fracture and cylinder - hole/perforated.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient's tactra penile prothesis, exhibited a broken cylinder.A surgical procedure was performed during which was identified that the bone anchors used to hold it in place, tore through the silicone of the cylinder.The tactra was removed and replace with an inflatable penile prosthesis (ipp).No 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: 24434573
• Report Number: 2124215-2026-10242
• Device Sequence Number: 16026580
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: (01)08714729979340(17)280404(10)40059702
• 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: 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): 04/21/2026

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: 0040059702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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: 33 YR
• Patient Sex: Unknown