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

Model Number	72404234-14
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis ipp presented with a device that did not inflate.A revision surgery was performed, during which the physician confirmed that the device did not inflate due to the pump not transferring fluid to the cylinders.The cylinders and pump were explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a device that did not inflate.A revision surgery was performed, during which the physician confirmed that the device did not inflate due to the pump not transferring fluid to the cylinders.The cylinders and pump were explanted and 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.Visual inspection revealed ms pump tubing was worn down to the filament.Under microscope observation, the spring and poppet rod were misaligned in the ms pump.The misaligned ms pump was primed during the leakage test, and output fluid flowed from the suture tubing instead of the two clear tubing.Visual inspection showed both cylinders had wear at the fold from the middle to the proximal end, and both cylinders did not pass the leakage test.Based on the information available and analysis results, the allegations of inflation and mechanical issues were most likely related to the misaligned ms pump spring and poppet rod identified during testing; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 22891032
• Report Number: 2124215-2025-58803
• Device Sequence Number: 5916422
• Product Code: JCW
• UDI-Device Identifier: 00878953009803
• UDI-Public: (01)00878953009803(17)230111(10)1000512693
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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 Expiration Date: 01/11/2023
• Device Model Number: 72404234-14
• Device Catalogue Number: 72404234-14
• Device Lot Number: 1000512693
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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 1000298388, UPN 72404156; RESERVOIR LOT 1000298388, UPN 72404156
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male