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

Model Number	72404288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Deformity/ Disfigurement (2360); Swelling/ Edema (4577)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) stated he experienced an infection.He was febrile and required ambulance transport to the emergency room.He received iv antibiotics and tested positive for pseudomonas aeruginosa.He was discharged home on antibiotics but continued to experience swelling and a 90 degree penile curvature.A few days later, he underwent a surgical washout of the device with drain placement.At a recent follow up visit, the stitches were removed and the site was assessed; however, swelling and penile curvature persisted.The device remains implanted, and the patient will continue follow up with his physician.No additional information was provided.
Additional Manufacturer Narrative
Model number/catalog number: 720182-01.Serial number: n/a.Batch/lot number: 1100783222.Model/catalog description: reservoir.Unique identifier (udi) # (b)(4).
Additional Manufacturer Narrative
Model number/catalog number: 720182-01.Serial number: n/a.Batch/lot number: 1100783222.Model/catalog description: reservoir.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.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 disfigurement, fever, infection (bacterial) 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.The reported patient symptoms are known risk associated with this device type and indicated as such in the instructions for use.Based on the information available, the 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) stated he experienced an infection.He was febrile and required ambulance transport to the emergency room.He received iv antibiotics and tested positive for pseudomonas aeruginosa.He was discharged home on antibiotics but continued to experience swelling and a 90 degree penile curvature.A few days later, he underwent a surgical washout of the device with drain placement.At a recent follow up visit, the stitches were removed and the site was assessed; however, swelling and penile curvature persisted.The device remains implanted, and the patient will continue follow up with his physician.No additional information was provided.

• 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
• MDR Report Key: 24691889
• Report Number: 2124215-2026-16459
• Device Sequence Number: 18573533
• Product Code: JCW
• UDI-Device Identifier: 00878953003917
• UDI-Public: (01)00878953003917(17)300713(10)1100759479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 72404288
• Device Catalogue Number: 72404288
• Device Lot Number: 1100759479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 07/14/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male