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

Model Number	72404273
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for pump: (b)(4).D4 unique identifier (udi) for reservoir: (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a crack in the pump connecting tube was found.The ipp was removed and replaced, while the existing reservoir was kept in the patient and a new one was added to the system.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for pump: (b)(4).D4 unique identifier (udi) for reservoir: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Both cylinders were microscopically inspected and leak testing.It was found that both cylinders had holes in the outer tube caused by kink resistant tubing (krt) wear at the proximal end.Additionally, both cylinders exhibited leakage associated with krt wear in the same area.Momentary squeeze (ms) pump was microscopically inspected and leak testing.Ms pump passed visual inspection, leak and functional testing.Based on the information available and analysis results, the hole and leak identified in both cylinders could have caused or contributed to the reported clinical observation of mechanical problem.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a crack in the pump connecting tube was found.The ipp was removed and replaced, while the existing reservoir was kept in the patient and a new one was added to the system.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: 23722426
• Report Number: 2124215-2025-87142
• Device Sequence Number: 8460359
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: (01)00878953003801(17)240528(10)1000273908
• 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: 2022
• 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
• Report Date (Section B): 02/13/2026

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: 05/28/2024
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 1000273908
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2019
• 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 1100080125; PUMP: UPN 72404310 / LOT 1100080125; RESERVOIR: UPN 72404161 / LOT 1100072049; RESERVOIR: UPN 72404161 / LOT 1100072049
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male