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

Model Number	72404230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced erosion of the cylinder into the urethra.The physician believes the patient left the device activated for prolonged periods.A surgical procedure was performed to remove ipp.No additional patient complications were reported.
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.There was no report of a device performance allegation.The reported patient symptom is a known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced erosion of the cylinder into the urethra.The physician believes the patient left the device activated for prolonged periods.A surgical procedure was performed to remove ipp.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number 720185-01.Serial number n/a.Batch/lot number 1100598682.Model/catalog description eservoir 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.There was no report of a device performance allegation.The reported patient symptom of erosion is a known risk associated with this device type and indicated as such in the instructions for use.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 erosion was defined in the product risk documentation.This type of event has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of adverse event related to patient condition was assigned to this investigation as the physician believes the patient left the device activated for prolonged periods, which could lead to erosion of the cylinder in the urethra as a result of leaving the device in an activated state.

• 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: 23945786
• Report Number: 2124215-2026-00110
• Device Sequence Number: 10683707
• Product Code: JCW
• UDI-Device Identifier: 00878953003436
• UDI-Public: (01)00878953003436(17)260717(10)1100549133
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 07/17/2026
• Device Model Number: 72404230
• Device Catalogue Number: 72404230
• Device Lot Number: 1100549133
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 07/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN: 720185-01 / LOT: 1100598682
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown