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

Model Number	72404438
Medical Device Problem Codes	Inflation Problem (1310); Migration (4003)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100623824.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.Device migration is acknowledged within the dfu and are not related to off label use or failure to follow instructions.The dfu provides guidance and instruction to achieve successful ams 700 implantation and to prevent migration issues.Incomplete inflation is acknowledged within the dfu and are not related to off label use or failure to follow instructions.The dfu provides guidance and instruction to achieve successful ams 700 implantation and to prevent inflation issues.The ifu provides guidance and instruction to achieve successful ams 700 implantation and to prevent tissue damage related symptoms.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 this patient with an inflatable penile prosthesis (ipp) implant device was unable to pump the device entirely.A surgical procedure was performed during which the device was explanted and replaced.Upon explant, there was distal cross over noted.There were no further patient complications 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: 24565335
• Report Number: 2124215-2026-13369
• Device Sequence Number: 12850887
• Product Code: JCW
• UDI-Device Identifier: 00191506021399
• UDI-Public: (01)00191506021399(17)270317(10)1100694796
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 03/10/2026

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: 72404438
• Device Catalogue Number: 72404438
• Device Lot Number: 1100694796
• 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: 02/11/2026
• Initial Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 03/17/2025
• 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: 81 YR
• Patient Sex: Male