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

Model Number	72404267
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient stated that the pump of this inflatable penile prosthesis was not working properly, as it was blocked and was not fully inflating the cylinders.One week later, a surgical procedure was performed, during which all components were removed and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that the patient stated that the pump of this inflatable penile prosthesis was not working properly, as it was blocked and was not fully inflating the cylinders.One week later, a surgical procedure was performed, during which 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.Both cylinders were microscopically inspected and tested for leaks.Wear at fold in the middle of each cylinder was noted; however, no leaks were identified.The pump was microscopically inspected, leak and functionally tested.Its kink resistant tubing (krt) was worn to the filament, but the component passed leakage and functional evaluation.The reservoir was microscopically inspected and tested for leaks.Wear at fold in its shell was noted, but no leaks were identified.Based on the information available and analysis results, the reported clinical observations could not be confirmed.

• 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: 19202848
• Report Number: 2124215-2024-25563
• Device Sequence Number: 12771062
• Product Code: FHW
• UDI-Device Identifier: 00878953003757
• UDI-Public: 00878953003757
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/04/2023
• Device Model Number: 72404267
• Device Catalogue Number: 72404267
• Device Lot Number: 1000579259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• 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: 72404155 / LOT: 1100142174.; RESERVOIR: UPN: 72404155 / LOT: 1100142174.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female