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); Mechanical Problem (1384)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that a patient with this inflatable penile prosthesis experienced an issue where the pump was not fully inflating the cylinders, resulting in insufficient rigidity.A revision surgery was performed during which the physician explanted and replaced the pump.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).Correction to field h6: device codes.
Event or Problem Description
It was reported that a patient with this inflatable penile prosthesis ipp presented with a capsule in the scrotum and experienced an issue where the pump did not fully inflate the cylinders, resulting in insufficient rigidity.A revision surgery was performed, during which the physician explanted and replaced the pump.There were no further patient complications.

• 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: 22188555
• Report Number: 2124215-2025-38299
• Device Sequence Number: 20979694
• Product Code: JCW
• UDI-Device Identifier: 00191506021399
• UDI-Public: (01)00191506021399(17)261024(10)1100618998
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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 Model Number: 72404438
• Device Catalogue Number: 72404438
• Device Lot Number: 1100618998
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/15/2025
• Date Device Manufactured: 10/24/2024
• 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 72018501, LOT 1100644655.; RESERVOIR UPN 72018501, LOT 1100644655.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male