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

Model Number	72404434
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in (b)(6) 2024, a surgical procedure was performed to implant a tenacio system (inflatable penile prosthesis).The patient then confirmed the pump seems stiffer and more difficult to squeeze, leading to more partial squeezes thus negating the greater potential efficiency and it is more prone to slip around in the scrotum while squeezing.The oversized deflation button is harder to successfully depress and the popping sound to confirm deflation was usually not audible and not reliable.The deflation stopped multiple times during the process.

• 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: 22061713
• Report Number: 2124215-2025-32226
• Device Sequence Number: 8468884
• Product Code: JCW
• UDI-Device Identifier: 00191506021351
• UDI-Public: (01)00191506021351(17)261002(10)1100604285
• 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: 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): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/02/2026
• Device Model Number: 72404434
• Device Catalogue Number: 72404434
• Device Lot Number: 1100604285
• 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: 04/29/2025
• Initial Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male