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

Model Number	72404273
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (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 the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cylinder connecting tube was identified.The cause of the crack in the connecting tube was not detailed by the hospital.All the components were removed and replaced.No patient complications were reported.
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the cylinder connecting tube was identified.The cause of the crack in the connecting tube was not detailed by the hospital.All the components were removed and replaced.No patient complications were reported.
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, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were visually inspected and tested for leaks.The first cylinder outer tube was detached and had broken fabric thread from kink resistant tubing (krt) wear in the proximal end of the cylinder.The first cylinder krt was worn down to the filament.The first cylinder had a bulge and fluid leak within the broken fabric thread in the proximal end of the cylinder.The second cylinder had tool mark in the proximal end of the cylinder.No leaks were found in the second cylinder.The rear tip extenders (rtes) were visually inspected.Rtes passed visual inspection.No damage or abnormalities were found.The pump was microscopically inspected, leak and functionally tested.The pump passed the visual inspection.No damage or abnormalities were found.No leaks were found in the pump.Functional test revealed that the pump did not pass the activation test.The reservoir was visually inspected and tested for leaks.The reservoir passed the visual inspection.No damage or abnormalities were found.No leaks were found in the reservoir.Based on the information available and analysis results, the reason for the mechanical issue and fluid leak was most likely determined to be the bulge and fluid leak found in the first cylinder.Additionally, the pump not passing the functional test could affect the 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.Based on the information available.A conclusion code of cause traced to component failure.

• 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: 23511893
• Report Number: 2124215-2025-80156
• Device Sequence Number: 21249454
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: (01)00878953003801(17)280424(10)1100293007
• 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: 2023
• 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): 01/20/2026

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 Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 1100293007
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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: 1100258979; PUMP: UPN: 72404310 / LOT: 1100258979; RESERVOIR: UPN: 72404161 / LOT: 1100250055; RESERVOIR: UPN: 72404161 / LOT: 1100250055
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male