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

Model Number	72404253
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that, during post-operative recovery of this inflatable penile prosthesis (ipp) procedure, the device exhibited improper inflation and deflation.The physician observed signs of a potential loss of fluid, as the saline volume in the reservoir consistently decreased.A week later, a revision surgery was performed, during which a leak due to a small hole at the distal tip of the right cylinder was identified; therefore, cylinders and pump were removed and replaced.No patient complications were reported.

• Brand Name: AMS 700 LGX MS PUMP
• 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: 22292394
• Report Number: 2124215-2025-38993
• Device Sequence Number: 8875901
• Product Code: JCW
• UDI-Device Identifier: 00878953003610
• UDI-Public: (01)00878953003610(17)260814(10)1100569994
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 06/19/2025

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: 08/14/2026
• Device Model Number: 72404253
• Device Catalogue Number: 72404253
• Device Lot Number: 1100569994
• 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: 05/26/2025
• Initial Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 08/14/2024
• 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 1100570544.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male