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

Model Number	72404292
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the pump connecting tube was identified.The pump and one reservoir were 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.The pump was microscopically inspected, leak and functionally tested.Microscope examination revealed that the pump kink resistant tubing (krt) were worn to the filament.The pump passed the leakage test.The pump failed the functional test.Based on the information available and analysis results, the allegation of mechanical issue was most likely determined to be the pump failure in the functional test; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the pump connecting tube was identified.The pump and one reservoir were 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: 20365316
• Report Number: 2124215-2024-61803
• Device Sequence Number: 12477560
• Product Code: FHW
• UDI-Device Identifier: 00878953003948
• UDI-Public: 00878953003948
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/02/2025

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: 05/20/2021
• Device Model Number: 72404292
• Device Catalogue Number: 72404292
• Device Lot Number: 0136549003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 01/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PUMP: LOT: 144041005 UPN: 72404310; PUMP: LOT: 144041005 UPN: 72404310; RESERVOIR: LOT: 133251011 UPN: 72404161; RESERVOIR: LOT: 133251011 UPN: 72404161; RTE: LOT: 132423013 UPN: 72403872; RTE: LOT: 132423013 UPN: 72403872
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male