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

Model Number	72404252
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with a history of erectile dysfunction and an inflatable penile prosthesis (ipp) implant device noted that the device was not working as there was fluid loss.The fluid loss was identified by there being air in the pump.The physician removed and replaced the entire device through replacement surgery, and there were no patient signs or symptoms reported at this time.
Additional Manufacturer Narrative
B3: date is unknown, so estimated date was entered.D10: concomitant product udi for reservoir is (b)(4).H6: 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.Fluid loss and fluid leakage are acknowledged within the dfu and are not related to off label use or failure to follow instructions.The dfu provides guidance and instruction to achieve successful ams 700 implantation and to prevent fluid loss.The dfu instructs repeat steps 6 and 7 until no bubbles are noted in the graduate during deflation, after the air has been removed, inject sterile normal saline (approximately 20 ml-30 ml) without injecting an air bubble, use the partially filled syringe to aspirate all air from the cylinder, and then slowly fill the cylinder with sterile normal saline (approximately 20 ml-30 ml) without injecting an air bubble, and to allow the air to be expelled from the pump and tubing, continue to squeeze and release the pump bulb 2-3 more times until no air bubbles appear in the graduate (these squeezes can be softer).Let the pump bulb completely refill before each squeeze.The dfu provides guidance and instruction to achieve successful ams 700 implantation and to prevent air in system.Based on the information available the cause that contributed to the reported event cannot be established.

• 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 ; 5086521217
• MDR Report Key: 23968850
• Report Number: 2124215-2026-00487
• Device Sequence Number: 18104139
• Product Code: JCW
• UDI-Device Identifier: 00878953003603
• UDI-Public: (01)00878953003603(17)130222(10)698087002
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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
• Report Date (Section B): 01/05/2026

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: 02/22/2013
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 698087002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 03/09/2011
• 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: LOT:704271014 UPN 72404155 RESERVOIR 65 ML PC/IZ.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male