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

Model Number	72404253-12
Medical Device Problem Codes	Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (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.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited fluid loss and inflation issues.During the surgical procedure, a small pinhole-sized leak was identified in the left cylinder.Additionally, air was observed within the device, and the pump bulb remained collapsed.The entire prosthetic system was explanted and replaced with a new ipp.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: 23425680
• Report Number: 2124215-2025-77109
• Device Sequence Number: 9798586
• Product Code: JCW
• UDI-Device Identifier: 00878953009827
• UDI-Public: (01)00878953009827(17)250906(10)1100356288
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 10/30/2025

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: 09/06/2025
• Device Model Number: 72404253-12
• Device Catalogue Number: 72404253-12
• Device Lot Number: 1100356288
• 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: 10/07/2025
• Initial Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 09/07/2023
• 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: 1100358497
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown