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

Model Number	72404281
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) did not rebound, and the device was not working properly.A surgical procedure was performed, which revealed that the tube connecting the pump to the device had become disconnected.Therefore, the cylinders and pump were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the cylinders and ms pump of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and tested for leaks.The first cylinder had a hole in the proximal end of the cylinder from sharp instrument.The first cylinder had wear at fold in the middle of the cylinder.The first cylinder had a leak from sharp instrument damage.The second cylinder had a hole in the distal end of the cylinder and tool marks from sharp instrument.The outer sleeve was cut from sharp instrument in the distal end.The second cylinder had a leak from sharp instrument damage in the distal end of the cylinder.The ms pump was microscopically inspected and tested for leaks.It was not functionally tested due to bodily fluid contamination identified within it.In addition, the ms pump kink resistant tubing (krt) had filament extended from explant procedure.No leaks were found in the pump.Based on the information available and analysis results, without a functional testing of the contaminated pump, the allegation of mechanical issue is unable to be confirmed.Additionally, since the tubing was not returned for analysis, the reported allegation of tube disconnection is unable to be confirmed.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 unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) did not rebound, and the device was not working properly.A surgical procedure was performed, which revealed that the tube connecting the pump to the device had become disconnected.Therefore, the cylinders and pump were removed and replaced.No patient complications were 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: 23343932
• Report Number: 2124215-2025-74896
• Device Sequence Number: 9461053
• Product Code: JCW
• UDI-Device Identifier: 00878953003849
• UDI-Public: (01)00878953003849(17)270103(10)1100059661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/26/2026

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: 72404281
• Device Catalogue Number: 72404281
• Device Lot Number: 1100059661
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 70 KG