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); Discomfort (2330); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with a tactra penile prosthesis is experiencing pain and discomfort in the glans area, attributed to malpositioning of the distal tip of the device.This has led to penile size reduction, glans drooping, and loss of organ functionality.An ultrasound was performed, and surgical intervention has been scheduled to reconstruct the corpora cavernosa and replace the penile prosthesis.No additional information has been reported at this time.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are known risk associated with this device type and indicated as such in the instructions for use.The reason for discomfort, disfigurement, pain, malposition of device was determined to be due to a malposition error during the original implantation procedure.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that the patient with a tactra penile prosthesis is experiencing pain and discomfort in the glans area, attributed to malpositioning of the distal tip of the device.This has led to penile size reduction, glans drooping, and loss of organ functionality.An ultrasound was performed, and surgical intervention has been scheduled to reconstruct the corpora cavernosa and replace the penile prosthesis.No additional information has been reported at this time.
Event or Problem Description
It was reported that the patient with a tactra penile prosthesis is experiencing pain and discomfort in the glans area, attributed to malpositioning of the distal tip of the device.This has led to penile size reduction, glans drooping, and loss of organ functionality.An ultrasound was performed, and surgical intervention has been scheduled to reconstruct the corpora cavernosa and replace the penile prosthesis.No additional information has been reported at this time.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem correction to g1: mfr site facility name.Correction to g1: mfr site address 1.Correction to g1: mfr site city.Correction to g1: mfr site state.Correction to g1: mfr site zip/post code.Correction to g1: mfr site country.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported symptoms of tissue damage, discomfort, disfigurement, pain and the reported malposition of device was most likely determined to be the malposition error during the original implantation procedure.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The device instructions for use (ifu) was reviewed.The reported patient symptoms of tissue damage, discomfort, disfigurement, and pain was found to be listed in the ifu.A risk review was completed and confirmed that the events of tissue damage, discomfort, disfigurement, pain, malposition were 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, a conclusion code of unintended use error caused or contributed to event 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 MA 01752 ; EI 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23129533
• Report Number: 2124215-2025-66756
• Device Sequence Number: 21142976
• Product Code: FAE
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

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: 0040262110
• Was Device Available for Evaluation?: No
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 05/27/2026
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/30/2025; 06/25/2026
• Date Device Manufactured: 10/02/2024
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male