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

Model Number	72404439
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Hematoma (1884); Inflammation (1932); Swelling/ Edema (4577)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced an edema, inflammation and hematoma in the scrotum.Upon revision, it was noted that the pump was not placed in the original pocket at implant; therefore, the pump has been repositioned and the hematoma was removed.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
• MDR Report Key: 21471187
• Report Number: 2124215-2025-11837
• Device Sequence Number: 3567754
• Product Code: JCW
• UDI-Device Identifier: 00191506021405
• UDI-Public: 00191506021405
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/26/2025

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 Expiration Date: 05/10/2026
• Device Model Number: 72404439
• Device Catalogue Number: 72404439
• Device Lot Number: 1100509788
• 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: 11/27/2024
• Initial Report FDA Received Date: 02/26/2025
• Date Device Manufactured: 05/10/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male