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

Model Number	72404233
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly and the patient noticed loss of rigidity during inflation.Upon inspection fluid loss from the cylinders was noticed possibly due to material fatigue or microperforation.As a result, the pump and cylinders were explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
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.D4.Concomitant product udi for reservoir is (b)(4).
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally and leak tested.No anomalies were found with the pump.The cylinders were microscopically inspected, and leak tested.The microscope test found that the first cylinder had a hole at corner of a fold and broken fabric threads in the proximal end of the cylinder and a wear at a fold and broken fabric threads from wear in the middle of the cylinder.The second cylinder had wear at fold in the proximal end and middle of the cylinder.He first cylinder did not pass the leak test, however, the second one did.Risk review: a risk review was completed using d055985 ams700 hazard analysis and confirmed that the events of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking), device has a fluid leak, and excess force or friction on silicone leads to stress, strains, holes or tears were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The device history record (dhr): the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Labeling review: 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 available information and analysis results, the leak at the corner of a fold from wear in the first cylinder, supports the reported clinical observations of cylinder fluid leak, cylinder hole/perforation, and device mechanical issue.D4.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working properly and the patient noticed loss of rigidity during inflation.Upon inspection fluid loss from the cylinders was noticed possibly due to material fatigue or microperforation.As a result, the pump and cylinders were explanted and replaced.No patient complications reported.

• 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: 23649528
• Report Number: 2124215-2025-83836
• Device Sequence Number: 9896673
• Product Code: JCW
• UDI-Device Identifier: 00878953003467
• UDI-Public: (01)00878953003467(17)231011(10)1100030753
• Combination Product (Y/N): Y
• 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): 02/27/2026

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: 10/11/2023
• Device Model Number: 72404233
• Device Catalogue Number: 72404233
• Device Lot Number: 1100030753
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: LOT 671134015, UPN 72404156; RESERVOIR: LOT 671134015, UPN 72404156
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown