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

Model Number	72404266
Medical Device Problem Codes	Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) stated that the device was not functioning as well as expected and was causing discomfort in the penis.Upon examination, it was determined that the device was not the appropriate size, as it was not positioned within the glans at the meatus.As a result, the cylinders were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 1100627507.Model/catalog description: reservoir 65 ml pc/iz.Unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Pain, mechanical malfunction and improperly sized cylinders are acknowledged within the instructions for uses (ifu) and are not related to off-label use or failure to follow instructions.A risk review was completed; tissue damage related symptoms, non-functioning device issues, and size related complications are defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The reported patient symptom of discomfort is a 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.

• Brand Name: AMS 700 CXR 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: 25353405
• Report Number: 2124215-2026-29276
• Device Sequence Number: 10302731
• Product Code: JCW
• UDI-Device Identifier: 00878953003740
• UDI-Public: (01)00878953003740(17)260515(10)1100511732
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 05/15/2026
• Device Model Number: 72404266
• Device Catalogue Number: 72404266
• Device Lot Number: 1100511732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 05/15/2024
• 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 Age: 82 YR
• Patient Sex: Male