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

Model Number	72404235
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was no longer working as expected due to inflation issues.A revision surgery was performed, upon examination air in the system was found.In addition, the pump was reported to stay flat when pressed.The device was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was no longer working as expected due to inflation issues.A revision surgery was performed, upon examination air in the system was found.In addition, the pump was reported to stay flat when pressed.The device was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders and reservoir were visually inspected and underwent leak testing.The fist cylinder had fluid leakage due to pinholes in the middle and proximal end consistent with sharp instrument damage.No visual damages nor abnormalities were found in the second cylinder, the reservoir or the rear tip extenders.The second cylinder and reservoir passed leak testing.The pump was visually inspected and underwent leak and functional testing.The pump kink resistant tubing (krt) was worn to the filament.The pump passed leak testing; however, it did not pass activation tests.Based on the information available and analysis results, the pump not passing activation tests could have caused or contributed to the reported clinical observation of mechanical issue; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 18627365
• Report Number: 2124215-2024-05298
• Device Sequence Number: 7889372
• Product Code: FHW
• UDI-Device Identifier: 00878953003481
• UDI-Public: 00878953003481
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/10/2024

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: 72404235
• Device Catalogue Number: 72404235
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown