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

Model Number	72404257
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented an inflation problem, it was reported that the pump was not working due to a fluid loss from two small holes in tubing.The ipp was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).The device is not available for analysis; therefore, no physical 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.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The first cylinder was microscopically inspected and leak testing.It was found that there was wear at a fold in the middle of the cylinder.Additionally, it was observed that the tubing had worn to the filament and a hole fatigue.The cylinder did not pass the leakage testing due to the leak found in the tube.The second cylinder was microscopically inspected and leak testing.It was found that there was wear at a fold in the middle of the cylinder.The cylinder passed the leakage testing.Momentary squeeze (ms) pump was microscopically inspected and passed visual inspection and the leakage test.However, ms pump did not pass valve de active state test.Flat reservoir was visually inspected, and it was observed to have wear at a fold in reservoir shell.Flat reservoir passed leakage test.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of inflation issue, fluid leak and hole/perforate was defined in the product risk documentation.Based on the information available and analysis results, the hole and leak identified in one of the cylinders could have caused or contributed to the reported clinical observation of mechanical problem.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented an inflation problem, it was reported that the pump was not working due to a fluid loss from two small holes in tubing.The ipp was explanted and replaced.There were no patient complications 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: 23956999
• Report Number: 2124215-2026-00252
• Device Sequence Number: 12197240
• Product Code: JCW
• UDI-Device Identifier: 00878953003658
• UDI-Public: (01)00878953003658(17)190913(10)187255010
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 09/13/2019
• Device Model Number: 72404257
• Device Catalogue Number: 72404257
• Device Lot Number: 0187255010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2017
• 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 0187084006.; RESERVOIR: UPN 720185-01 / LOT 0187084006.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male