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

Model Number	72404438
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number 72404155.Serial number n/a.Batch/lot number n/a.Model/catalog description reservoir 65 ml pc/iz.Unique identifier (udi) # (b)(4).Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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 symptoms of swelling and scarring are acknowledged within the dfu and is not related to off-label use or failure to follow instructions.The reported patient symptom of swelling and scarring are known risks associated with this device type and indicated as such in the instructions for use.A risk review was completed, and tissue damage related symptoms 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.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
Please update the complaint summary and b5 to the following: it was reported that the patient with an inflatable penile prosthesis (ipp) was unable to activate the device during the postoperative appointment due to persistent swelling.One month later, it was noted that the device remained difficult to cycle.The physician later observed that the patient had scarring around the pump, which contributed to the difficulty cycling the device.A surgical procedure was performed 98 days after the device was originally implanted, during which the device was tested and found to function as expected.However, it was noted that the patient had an almost keloid-like scar around the pump, potentially related to the coating on the pump, although this was not confirmed.As a result, the pump was relocated to the other hemiscrotum.No additional information was provided.

• 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
• MDR Report Key: 24613083
• Report Number: 2124215-2026-14494
• Device Sequence Number: 9640419
• Product Code: JCW
• UDI-Device Identifier: 00191506021399
• UDI-Public: (01)00191506021399
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/16/2026
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 109 KG