MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number 72404238

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994)

Event Date 01/06/2024

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 reported patient symptoms are a known risk associated with implant of these devices 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 Description

It was reported that the cylinder of this inflatable penile prosthesis extruded through the meatus, causing pain for the patient.It is believed the extrusion was related to light modeling to reduce penile curvature due to peyronies disease performed post-implant by the physician.A revision surgery was performed to explant and plugged the cylinder, and another implant will be performed once the healing process is complete.No additional patient complications were reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• 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: 18553464
• MDR Text Key: 333374265
• Report Number: 2124215-2024-02978
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003511
• UDI-Public: 00878953003511
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1100356616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2024
• Initial Date FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• 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: RESERVOIR: UPN: 720185-01 / LOT: 1100366202
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR