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

Model Number	72404239
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient stated that this inflatable penile prosthesis (ipp) stopped working since (b)(6) 2024.The patient stated that the doctor confirmed that it was a fluid leak, and a replacement would be needed.The patient stated that he experienced pain.No revision surgery has been informed, and no additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is: (b)(4).
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported fluid leak, mechanical issue and pain are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.The reported patient symptom of pain is known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient stated that his inflatable penile prosthesis (ipp) was not pumping correctly.One year later, the device stopped working.The patient stated that the physician confirmed a fluid leak and indicated that a replacement would be needed.Additionally, the patient reported experiencing pain.Several months later, a surgical procedure was performed to remove the ipp.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: 21805440
• Report Number: 2124215-2025-21850
• Device Sequence Number: 7408584
• Product Code: JCW
• UDI-Device Identifier: 00878953003528
• UDI-Public: (01)00878953003528(17)191115(10)1000009388
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/15/2019
• Device Model Number: 72404239
• Device Catalogue Number: 72404239
• Device Lot Number: 1000009388
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 11/15/2017
• 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: 1000209639.; RESERVOIR: UPN: 720185-01 / LOT: 1000209639.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male