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

Model Number 720185-01

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Air/Gas in Device (4062)

Patient Problem Discomfort (2330)

Event Date 11/21/2023

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.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 presented with an inflatable penile prosthesis (ipp) that was no longer inflating properly, and the patient was no longer able to maintain an erection.Approximately three months ago, the patient heard a snap sound and the device stopped working properly.The physician performed a ct scan for abdominal discomfort and identified a fluid leak from the reservoir.There was also air found in the component.There were no patient complications reported; however, the physician has scheduled a revision of the device for (b)(6) 2023.

• 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: 18314723
• MDR Text Key: 330327070
• Report Number: 2124215-2023-70553
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005669
• UDI-Public: 00878953005669
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2017
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 931912018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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: CYLINDERS: UPN: 72404251 LOT: 911463004
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male