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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis was removed and replaced due to a total loss of fluid.There were no patient complications reported.
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.
Additional Manufacturer Narrative
Upon receipt, at our quality assurance laboratory.This inflatable penile prosthesis underwent a thorough analysis.Both cylinders were microscopically inspected and leak tested.The first cylinder presented buckling folds in the proximal end of its body, along with a leak, due to a hole in the at corner of a fold in the proximal end of the component.The second cylinder passed, leakage testing.However, upon microscopic evaluation, it was noted, that the component exhibited wear at fold in the middle and proximal end of its body.The kink resistant tubing (krt) of both components were worn to the filament.The pump was microscopically inspected, leak and functionally tested.A leak, due to a hole in the pump strain relief krt junction was identified.In addition, the component did not pass activation test, during functional examination.The reservoir was microscopically inspected and tested for leaks.Microscopic evaluation revealed, wear at the reservoir adapter and at a fold in the reservoir shell.Additionally, the krt was worn to the filament.No leaks were identified in the component.Based on the information available and analysis results, the fluid leak caused by a hole in the pump strain relief krt junction could have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported, that this inflatable penile prosthesis was removed and replaced, due to a total loss of fluid.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: 19152759
• Report Number: 2124215-2024-23927
• Device Sequence Number: 20957590
• 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: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 01/25/2023
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 1000518314
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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: 720185-01 / LOT: 1100020230; RESERVOIR: UPN: 720185-01 / LOT: 1100020230
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown