MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404292
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the right cylinder was found.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).D4 unique identifier (udi) for pump: (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the right cylinder was found.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).D4 unique identifier (udi) for pump: (b)(4).Upon receipt at our quality assurance laboratory, this device underwent a thorough analysis.The cylinders, pump and reservoir were microscopically examined, and leak tested; the cylinders were also pressure tested and the pump was functionally tested.No anomalies were found with the pump.Testing of the cylinders revealed that for bot cylinders, there were holes in the outer tube from kink resistant tubing (krt) wear in the proximal end of the cylinder.The cylinders passed leakage and pressure testing.Regarding the reservoir, it was observed to had wear at a fold in reservoir shell; the component passed leakage testing.Based on the information available and analysis results, the hole identified in both cylinders could have caused or contributed to the reported clinical observation of mechanical problem and confirmed the reported hole/perforation allegation.

• Brand Name: AMS 700 LGX
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• 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: 23323035
• Report Number: 2124215-2025-73587
• Device Sequence Number: 10572748
• Product Code: JCW
• UDI-Device Identifier: 00878953003948
• UDI-Public: (01)00878953003948(17)260712(10)1000591063
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 07/12/2026
• Device Model Number: 72404292
• Device Catalogue Number: 72404292
• Device Lot Number: 1000591063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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: PUMP: UPN 72404310 / LOT 1000586367; PUMP: UPN 72404310 / LOT 1000586367; RESERVOIR: UPN 720182-01 / LOT 1000087000; RESERVOIR: UPN 720182-01 / LOT 1000087000
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male