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

Model Number	72404236
Medical Device Problem Codes	Nonstandard Device (1420); Migration (4003)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cylinder of this inflatable penile prosthesis (ipp) had herniated.A surgical procedure was performed to remove and replace the cylinders and pump.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number 720185-01.Serial number n/a.Batch/lot number 1100340599.Model/catalog description reservoir flat iz 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.The reported migration and tissue damage are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.The reported migration and the reported patient symptom of tissue damage are known risks associated with this device type and indicated as such in the instructions for use.Based on a thorough review of the information, an investigation conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the cylinder of this inflatable penile prosthesis (ipp) had herniated.A surgical procedure was performed to remove and replace the cylinders and pump.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Model number/catalog number 720185-01, batch/lot number 1100340599, model/catalog description reservoir flat iz 100 ml, unique identifier (udi) # (b)(4).Upon receipt at our quality assurance laboratory, the cylinders and pump of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and tested for leaks.Microscope examination revealed that both cylinders had wear at fold in the proximal end of the cylinder.No leaks were found in the cylinders.The ms pump was microscopically inspected, leak and functionally tested.The pump passed the visual inspection.No damage or abnormalities were found.No leaks were found in the pump.The pump passed the functional test.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 events of tissue damage and migration 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 and analysis results, a conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 24576155
• Report Number: 2124215-2026-13674
• Device Sequence Number: 9434901
• Product Code: JCW
• 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: 2023
• 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): 05/29/2026

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: 06/06/2024
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 1100141349
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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