MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TACTRA; Prosthesis Penile

Model Number	720081-01
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted with a tactra penile prosthesis experienced glans penile pain, loss of penile length, and glans instability.The patient also reported that the prosthesis was malpositioned relative to the glans.A penile ultrasound was performed and confirmed prosthesis malposition within the glans and glans instability, with the prosthesis noted to be poorly positioned in the glans.A revision procedure was scheduled to reconstruct the corpora cavernosa and replace the penile prosthesis.Subsequently, the revision surgery was performed, during which the tactra penile prosthesis was explanted and replaced with an inflatable penile prosthesis (ipp).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 E91 T 862; EI E91 T862
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50515523
• Report Number: 2124215-2026-46491
• Device Sequence Number: 13105379
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: (01)08714729979357(17)260509(10)27367372
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K183619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/09/2026
• Device Model Number: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0027367372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 05/10/2021
• 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: 65 YR
• Patient Sex: Male