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

Model Number	72404239
Medical Device Problem Codes	Degraded (1153); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient presented with a mechanical failure of his inflatable penile prosthesis (ipp).Tomography revealed an aneurysm in the cylinders at the base of the penile shaft, and the physician suspects erosion.Additionally, the device was not inflating properly, and the prosthesis presents axial instability.A revision surgery has been requested; no additional information was provided.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient presented with a mechanical failure of his inflatable penile prosthesis (ipp).Tomography revealed an aneurysm in the cylinders at the base of the penile shaft, and the physician suspects erosion.Additionally, the device was not inflating properly, and the prosthesis presents axial instability.A surgical procedure was performed to remove and replace the ipp.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient presented with a mechanical failure of his inflatable penile prosthesis (ipp).Tomography revealed an aneurysm in the cylinders at the base of the penile shaft, and the physician suspects erosion.Additionally, the device was not inflating properly, and the prosthesis presents axial instability.A revision surgery has been requested; no additional information was provided.

• Brand Name: AMS 700 CX MS 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: 21704198
• Report Number: 2124215-2025-18515
• Device Sequence Number: 4796922
• Product Code: JCW
• UDI-Device Identifier: 00878953003528
• UDI-Public: (01)00878953003528(17)260425(10)1100499465
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2025

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: 04/25/2026
• Device Model Number: 72404239
• Device Catalogue Number: 72404239
• Device Lot Number: 1100499465
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 04/08/2025; 05/20/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/29/2025; 06/11/2025
• Date Device Manufactured: 04/25/2024
• 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: 1100561612; RESERVOIR: UPN: 720185-01 / LOT: 1100561612; RESERVOIR: UPN: 720185-01 / LOT: 1100561612
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male