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

Model Number	72404232
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced that the erection did not remain stiff during sexual intercourse, although the device remained rigid when not used for intercourse.Pump difficulty was reported; however, the cylinders were able to inflate.A surgical procedure was performed in which the pump was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
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.Based on the information available, a conclusion code of cause not established was assigned to this investigation.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The pump was subjected to microscopic inspection, leak testing, and functional testing.All three tests were successfully completed and passed.No damage, abnormalities, or functional issues were identified.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 mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) 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 and analysis results, the reported clinical observations of device inflation issue and pump mechanical issue could not be confirmed, as they were not substantiated during functional testing.Therefore, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced that the erection did not remain stiff during sexual intercourse, although the device remained rigid when not used for intercourse.Pump difficulty was reported; however, the cylinders were able to inflate.A surgical procedure was performed in which the pump was explanted and replaced.There were no patient complications reported.

• 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: 25230328
• Report Number: 2124215-2026-27154
• Device Sequence Number: 16041614
• Product Code: JCW
• UDI-Device Identifier: 00878953003450
• UDI-Public: (01)00878953003450(17)270822(10)1100782797
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2026

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: 72404232
• Device Catalogue Number: 72404232
• Device Lot Number: 1100782797
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/08/2026
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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 Sex: Unknown