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

Model Number	72404236
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery due to a total fluid loss from the system.The fluid loss was identified because the device did not inflate.The location, source and cause of the fluid loss were not identified.All components were removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected, and leak tested.Both cylinders had wear at fold in the middle of the cylinder.Both cylinders passed the leakage test.The pump was microscopically inspected, and leak tested.Under microscope observation, contamination (bodily fluid) was found within pump.The pump passed the leakage test.To avoid damaging the test equipment, the pump was not functionally tested.Based on the information available and analysis results, the allegation of fluid leak is unable to be confirmed.The pump was returned with contamination and could not be functionally tested.Based on this investigation a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established has been chosen.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery due to a total fluid loss from the system.The fluid loss was identified because the device did not inflate.The location, source and cause of the fluid loss were not identified.All components were removed and replaced.There were no patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: 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: 20571524
• Report Number: 2124215-2024-68245
• Device Sequence Number: 18286431
• Product Code: FHW
• UDI-Device Identifier: 00878953003498
• UDI-Public: 00878953003498
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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 Expiration Date: 07/04/2025
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 1100324410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN: 720185-01 / LOT: 1100416756; RESERVOIR: UPN: 720185-01 / LOT: 1100416756
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown