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

Model Number	72404302
Medical Device Problem Codes	Deflation Problem (1149); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, one week after the implant procedure, the pump of this inflatable penile prosthesis was pressed, and it automatically filled with fluid and remained swollen.It was noted that the component remained swollen even after troubleshooting was attempted from the medical staff.In addition, the cylinders were also not deflating after the pump was pressed.The physician believes it happened because the discharge button could not bounce back normally, as it did not have rebound force; therefore, the component was removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) pump underwent a thorough analysis.The component was microscopically inspected, leak and functionally tested.No damage or abnormalities were noted, no leaks were identified in the pump.Based on the information available and analysis results, the reported clinical observations could not be confirmed.
Event or Problem Description
It was reported that, one week after the implant procedure, the pump of this inflatable penile prosthesis was pressed, and it automatically filled with fluid and remained swollen.It was noted that the component remained swollen even after troubleshooting was attempted from the medical staff.In addition, the cylinders were also not deflating after the pump was pressed.The physician believes it happened because the discharge button could not bounce back normally, as it did not have rebound force; therefore, the component was removed and replaced.There were no patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: 19038820
• Report Number: 2124215-2024-20106
• Device Sequence Number: 20953014
• Product Code: FHW
• UDI-Device Identifier: 00878953005737
• UDI-Public: 00878953005737
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2024

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 Model Number: 72404302
• Device Catalogue Number: 72404302
• Device Lot Number: 1100350287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 75 KG