MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CX MS Pump; prosthesis, penis, inflatable

Model Number	72404282
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Impaired Healing (2378); Fluid Discharge (2686)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient with an inflatable penile prosthesis (ipp) experienced continuous fluid discharge from the scrotal wound at the junction of the penis and the scrotum, and infection at the scrotum.The wound could not heal completely.A surgical procedure was performed during which the entire device was explanted.The patient was stable following the procedure, and no additional information was provided.
Event or Problem Description
It was reported that this patient with an inflatable penile prosthesis (ipp) experienced exudation of interstitial fluid from the scrotal wound, infection, and the wound could not heal completely.A surgical procedure was performed during which the entire device was explanted.The patient was stable following the procedure, and no additional information was provided.
Additional Manufacturer Narrative
Model number/catalog number: 72018201 serial number: n/a batch/lot number: 1100562589 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Infection, fluid discharge, and impaired healing are acknowledged within the ifu and are not related to off label use or failure to follow instructions.The reported patient symptoms are known risks associated with this device type and are indicated as such in the instructions for use.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the events of fluid discharge, healing impaired, and infection were 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 adverse event related to procedure was assigned to this investigation as the patient had impaired healing and continuous fluid discharge from the site of the wound after the procedure from the infection that developed.Per the physician they described that before the procedure the patient showed no signs of infection, and the relevant tests were normal.However, within two to three after the procedure, there was repeated fluid leakage, which the physician considered to be an infection that occurred after the ipp implantation.No device malfunctions were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72018201.Serial number: n/a.Batch/lot number: 1100562589.Model/catalog description: reservoir flat 100 ml.Unique identifier (udi) #: (b)(4).

• 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 ; +1(508)652-1217
• MDR Report Key: 50202743
• Report Number: 2124215-2026-42766
• Device Sequence Number: 5507660
• Product Code: JCW
• UDI-Device Identifier: 00878953003856
• UDI-Public: (01)00878953003856(17)290425(10)1100497541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2026

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: 72404282
• Device Catalogue Number: 72404282
• Device Lot Number: 1100497541
• 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: 07/29/2026
• Supplement Date Received by Manufacturer: Not provided; 09/01/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/04/2026; 09/21/2026
• Date Device Manufactured: 04/26/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male