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

Model Number	720080-01
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a surgical procedure to replace the temporary inflatable penile prosthesis (ipp) malleable device with inflatable cylinders due to erosion of the cylinder.The previous cylinders were removed and new cylinders were implanted.The previous reservoir stayed in and was connected to the new ipp cylinders.The patient is expected to fully recover following the procedure.
Additional Manufacturer Narrative
Corrected: b5 describe event or problem, d1/d2 brand name/common device name, g1 manufacturing site information, h6 device code.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptom is a known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to remove and replace the left cylinder of this inflatable penile prosthesis (ipp) due to erosion.The left cylinder was explanted and replaced with a malleable prosthesis cylinder while the original right cylinder remained implanted.A second procedure was later performed where both the inflatable and malleable cylinders and pump were removed, replaced with new ipp components, and connected to the existing reservoir.No further patient complications were reported.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to remove and replace the left cylinder of this inflatable penile prosthesis (ipp) due to erosion.The left cylinder was explanted and replaced with a malleable prosthesis cylinder while the original right cylinder remained implanted.A second procedure was later performed where both the inflatable and malleable cylinders and pump were removed, replaced with new ipp components, and connected to the existing reservoir.No further patient complications were reported.
Additional Manufacturer Narrative
There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• 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 MN ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20177594
• Report Number: 2124215-2024-56352
• Device Sequence Number: 20976863
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: 08714729979340
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 720080-01
• Device Catalogue Number: 720080-01
• Device Lot Number: 0030345720
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 10/21/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/04/2024; 10/31/2024
• Date Device Manufactured: 10/03/2022
• 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: 69 YR
• Patient Sex: Male