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

Model Number	72404231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404155 serial number: n/a.Batch/lot number: 1100254416 model/catalog description: reservoir 65 ml pc/iz unique identifier (udi) #: (b)(4).B3: date is unknown, so estimated date was entered.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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.The reported patient symptom of infection and pain was found to be listed in the ifu.Based on the information available, the conclusion code of known inherent risk was assigned to this investigation.
Event or Problem Description
It was reported that this patient with an inflatable penile prosthesis (ipp) implant device and non-boston scientific reservoir experienced pain and an infection in the abdominal region.The bsc ipp device was working well; however, it was suspected that the non-bsc ipp reservoir may have contributed to the infection and pain as these clinical signs originating at the abdominal area.A surgical procedure was performed a few days later during which the entire bsc ipp device and non-bsc ipp reservoir were explanted and replaced with a tactra device.The physician treated the infection by prescribing antibiotics.There were no further patient complications reported.

• Brand Name: AMS 700 CX 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 ; 5086521217
• MDR Report Key: 24973465
• Report Number: 2124215-2026-22192
• Device Sequence Number: 20078453
• Product Code: JCW
• UDI-Device Identifier: 00878953003443
• UDI-Public: (01)00878953003443(17)250711(10)1100326947
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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): 04/23/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/11/2025
• Device Model Number: 72404231
• Device Catalogue Number: 72404231
• Device Lot Number: 1100326947
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 07/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male