MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS DURA II POSTIONABLE PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number 72009311

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The device instructions for use (ifu) list injury, nos (not otherwise specified) as a potential adverse event associated with implant of these devices.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the patient with this dura ii postionable penile prosthesis underwent a surgical procedure to replace this device due to possible infection, though no specific symptoms were reported.Upon explant, no infection was observed, and a new malleable device was implanted.No further patient complications were reported.

• Brand Name: AMS DURA II POSTIONABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18889229
• MDR Text Key: 337482890
• Report Number: 2124215-2024-14979
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K920420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2014
• Device Model Number: 72009311
• Device Catalogue Number: 72009311
• Device Lot Number: 581677001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TIP DURA-II: 72009329/575806010
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR