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

Model Number	72404250
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis was not working properly, and the cylinders were not remaining inflated.A surgical procedure was performed to remove and replace all the components.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.No damage or abnormalities were noted, no leaks were identified.The pump was microscopically inspected, and leak and functionally tested.Upon microscopic evaluation, no damage or abnormalities were noted, and no leaks were identified.However, the pump did not pass the activation test during functional examination.The reservoir was microscopically inspected and tested for leaks.Wear at fold in the component shell was noted, but the reservoir passed the leakage test.Based on the information available and analysis results, the pump not passing the functional inspection could have caused or contributed to the reported clinical observation of mechanical issue.
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis was not working properly, and the cylinders were not remaining inflated.A surgical procedure was performed to remove and replace all the components.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: 18882930
• Report Number: 2124215-2024-14776
• Device Sequence Number: 11522575
• Product Code: FHW
• UDI-Device Identifier: 00878953003580
• UDI-Public: 00878953003580
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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: 12/21/2022
• Device Model Number: 72404250
• Device Catalogue Number: 72404250
• Device Lot Number: 1000507638
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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: 1000444090; RESERVOIR: UPN: 720185-01 / LOT: 1000444090
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown