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

Model Number	72404463
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon attempted to activate the pump of this inflatable penile prosthesis (ipp), and when they reached what they perceived as 75% fullness with full pumps, the cylinders would not fill any further.Multiple attempts were made to pump and inflate, but the cylinders only reached full inflation with flutter pumps for the last 25%.No surgical intervention has been informed, and no additional information was provided.

• Brand Name: AMS 700 CXR 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: 21322790
• Report Number: 2124215-2025-06304
• Device Sequence Number: 15469499
• Product Code: JCW
• UDI-Device Identifier: 00191506021528
• UDI-Public: 00191506021528
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 02/06/2025

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: 08/09/2026
• Device Model Number: 72404463
• Device Catalogue Number: 72404463
• Device Lot Number: 1100565634
• 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: 01/16/2025
• Initial Report FDA Received Date: 02/06/2025
• Date Device Manufactured: 08/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN: 720185-01 / LOT: 1100572833
• Patient Age: 54 YR
• Patient Sex: Male