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

Model Number 72404231

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2023

Event Type  Injury  

Event Description

It was reported that the patient with this inflatable penile prosthesis (ipp) experienced floppy glans syndrome due to the cylinders not being long enough for his anatomy.A revision surgery was performed to explant and replaced the cylinders with a larger one.No additional patient complications were reported.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The cylinders being too short for the patient anatomy could have caused or contributed to the reported patient symptom of floppy glans, which is 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 unintended use error caused or contributed to event was assigned to this investigation as the event was determined to be unintentional or inadvertent interaction.

Event Description

It was reported that the patient with this inflatable penile prosthesis (ipp) experienced floppy glans syndrome due to the cylinders not being long enough for his anatomy.A revision surgery was performed to explant and replaced the cylinders with a larger one.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: 18455272
• MDR Text Key: 332254790
• Report Number: 2124215-2023-75002
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003443
• UDI-Public: 00878953003443
• 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: 02/13/2024

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 Expiration Date: 10/25/2013
• Device Model Number: 72404231
• Device Catalogue Number: 72404231
• Device Lot Number: 739094003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2011
• 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: 72404155 / LOT: 743110002; RESERVOIR: UPN: 72404155 / LOT: 743110002
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR