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

Model Number	72404273
Medical Device Problem Codes	Degraded (1153); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis was not working properly.Tests were performed and revealed an aneurysm in the left cylinder; therefore, a surgical procedure was performed to replace the device.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (b)(4).
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The cylinders were visually inspected and leak tested.Both cylinders showed frayed fabric threads from wear in the middle section.Leak testing revealed a bulge in the middle of each cylinder when inflated with a syringe.The reservoir was visually inspected and leak tested.Inspection revealed wear at a fold in the reservoir shell.Leak test passed.The pump was microscopically inspected, leaked and functionally tested.Microscopic inspection revealed a misaligned spring in the ms pump.Functional testing did not pass activation test 3, while the leak test passed.Based on the available information and analysis results, the bulge presented in both cylinders, could have caused or contributed to the reported clinical observations of cylinder bulge and device mechanical issue.Additionally, the pump not passing the functional test, could affect product performance.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.
Event or Problem Description
It was reported that this inflatable penile prosthesis was not working properly.Tests were performed and revealed an aneurysm in the left cylinder; therefore, a surgical procedure was performed to replace the device.No patient complications were reported.

• Brand Name: AMS 700 CX
• 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: 23286588
• Report Number: 2124215-2025-71135
• Device Sequence Number: 17510517
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: (01)00878953003801(17)230320(10)1000076718
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 03/20/2023
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 1000076718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2018
• 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: PUMP: UPN: 72404310/LOT: 1100373579; PUMP: UPN: 72404310/LOT: 1100373579; RESERVOIR: UPN: 72404161/LOT: 1100344229; RESERVOIR: UPN: 72404161/LOT: 1100344229
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male