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

Model Number	72404209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) developed a localized scrotal infection involving the pump site.The patient had previously undergone a revision procedure to exchange the tenacio pump with an ms pump.During the postoperative recovery period, the patient reported cycling the pump and returning to the gym for exercise.The patient subsequently experienced scrotal swelling and presented to the emergency department, where imaging identified a rim enhancing fluid collection surrounding the scrotal pump, consistent with a localized infection.A surgical procedure was performed in which the pump was explanted, metal tubing plugs were placed to retain the remaining components, and the scrotum was thoroughly irrigated.There were no further patient complications reported.
Additional Manufacturer Narrative
There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms of infection, swelling and fluid discharge are known risks and noted as such in the device instructions for use.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 fluid discharge, infection, and swelling was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) developed a localized scrotal infection involving the pump site.The patient had previously undergone a revision procedure to exchange the tenacio pump with an ms pump.During the postoperative recovery period, the patient reported cycling the pump and returning to the gym for exercise.The patient subsequently experienced scrotal swelling and presented to the emergency department, where imaging identified a rim enhancing fluid collection surrounding the scrotal pump, consistent with a localized infection.A surgical procedure was performed in which the pump was explanted, metal tubing plugs were placed to retain the remaining components, and the scrotum was thoroughly irrigated.There were no further patient complications reported.

• Brand Name: 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: 24134248
• Report Number: 2124215-2026-03883
• Device Sequence Number: 20197718
• Product Code: JCW
• UDI-Device Identifier: 00878953003351
• UDI-Public: (01)00878953003351(17)270709(10)1100757168
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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 Model Number: 72404209
• Device Catalogue Number: 72404209
• Device Lot Number: 1100757168
• 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: 12/25/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 07/09/2025
• 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: 59 YR
• Patient Sex: Male