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

Model Number	720082-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Fluid Discharge (2686)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this tactra penile prosthesis presented with an infection at the implant site two months post procedure.The patient noticed a small secretion from the incision site, which was treated with antibiotics, but was unsuccessful.An evaluation revealed the beginning of a possible cylinder prosthesis extrusion through a cavernous fistula.The tactra device is currently implanted, and the replacement surgery is already booked.There were no additional patient complications reported.
Additional Manufacturer Narrative
B3 approximated.
Additional Manufacturer Narrative
B3 approximated.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this tactra penile prosthesis presented with an infection at the implant site two months post procedure.The patient noticed a small secretion from the incision site, which was treated with antibiotics, but was unsuccessful.An evaluation revealed the beginning of a possible cylinder prosthesis extrusion through a cavernous fistula.The tactra device is currently implanted, and the replacement surgery is already booked.There were no additional patient complications reported.
Additional Manufacturer Narrative
B3 approximated.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Updated b5 describe event or problem, d6b explant date and h6 impact codes.
Event or Problem Description
It was reported that the patient with this tactra penile prosthesis presented with an infection at the implant site two months post procedure.The patient noticed a small secretion from the incision site, which was treated with antibiotics, but was unsuccessful.An evaluation revealed the beginning of a possible cylinder prosthesis extrusion through a cavernous fistula.The tactra device was explanted and replaced.There were no additional patient complications reported.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• 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: 20514533
• Report Number: 2124215-2024-66290
• Device Sequence Number: 7044960
• Product Code: FAE
• UDI-Device Identifier: 08714729979364
• UDI-Public: 08714729979364
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• 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): 12/11/2024

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 Model Number: 720082-01
• Device Catalogue Number: 720082-01
• Device Lot Number: 0040084793
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 10/28/2024; 11/20/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/14/2024; 12/11/2024
• Date Device Manufactured: 07/03/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male