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

Model Number	72404301
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was unable to press the inflatable penile prosthesis pump.A revision surgery was performed, during which the physician confirmed that the device was difficult to pump, resulting in the inability to inflate the device.The pump was replaced.No patient complications were reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a patient was unable to press the inflatable penile prosthesis ipp pump.A revision surgery was performed, during which the physician confirmed that the device was difficult to pump, resulting in the inability to inflate the device.The pump was replaced.No patient complications were reported.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.Microscope inspection revealed both cylinders passed the inspection.No damage or abnormalities were found.Both cylinders passed the leakage test.Microscope inspection of the ms pump revealed that the kink resistant tubing (krt) was worn to the filament, not passing the test.Leakage testing of the ms pump passed.Functional testing did not pass.The ms pump did not pass activation tests 2 and 3.Based on the information available and analysis results, the allegations of mechanical issue and the inflation issue were confirmed.Therefore, it can be concluded that the ms pump failure of activation tests 2 and 3 was the most probable cause.A conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS 700 LGX 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: 22159667
• Report Number: 2124215-2025-36858
• Device Sequence Number: 8683718
• Product Code: JCW
• UDI-Device Identifier: 00878953005720
• UDI-Public: (01)00878953005720(17)270711(10)1100154817
• 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: 2023
• 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): 07/24/2025

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: 72404301
• Device Catalogue Number: 72404301
• Device Lot Number: 1100154817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR LOT 1100295007, UPN 72018201.; RESERVOIR LOT 1100295007, UPN 72018201.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 85 KG