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

Model Number	72404238
Medical Device Problem Codes	Inflation Problem (1310); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01, serial number: n/a, batch/lot number: 1100100151, model/catalog description: reservoir flat iz 100 ml, unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Inflation issue is acknowledged within the instructions for use (ifu) and is not related to off-label use or failure to follow instructions.Based on the information available the cause that contributed to the reported event cannot be established; therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented unable to inflate the device.A revision surgery was performed in which physician explanted and replaced the device.There were no patient complications.

• 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: 25630756
• Report Number: 2124215-2026-34075
• Device Sequence Number: 9837184
• Product Code: JCW
• UDI-Device Identifier: 00878953003511
• UDI-Public: (01)00878953003511(17)230524(10)1000573186
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 05/24/2023
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1000573186
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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 Sex: Unknown