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

Model Number	72404432
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the events of malposition and erosion 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 a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk.
Event or Problem Description
It was reported that the patient implanted with this inflatable penile prosthesis (ipp) presented for routine follow-up at which time distal erosion of the right cylinder was observed.The cylinders and pump were explanted and replaced with new components while the reservoir was drained and refilled.The device was tested and found to function as expected.It was noted the patient had poor tissue quality which may have contributed to the erosion.No further patient complications were reported.

• Brand Name: AMS 700? CX TENACIO? 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 ; 5086521217
• MDR Report Key: 24888488
• Report Number: 2124215-2026-20423
• Device Sequence Number: 13235989
• Product Code: JCW
• UDI-Device Identifier: 00191506021337
• UDI-Public: (01)00191506021337(17)270123(10)1100663453
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 04/15/2026

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 Model Number: 72404432
• Device Catalogue Number: 72404432
• Device Lot Number: 1100663453
• 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: 03/17/2026
• Initial Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 01/23/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male