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

Model Number	72404232-10
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implantation of this inflatable penile prosthesis (ipp), intraoperative modeling was performed following placement of the implant.The tubing connected to the pump and cylinders was clamped during modeling and subsequently unclamped prior to device testing with connection to a surrogate reservoir.During functional testing, no tactile feedback was observed upon pump actuation, including absence of buzzing or vibration, and the pump did not function as intended, as fluid did not transfer into or out of the pump, resulting in no inflation or deflation.Troubleshooting attempts, including repeated inflation and deflation attempts and actuation of the pump sidebars, were unsuccessful.The surrogate reservoir was confirmed to be properly filled and connected prior to testing.No air was observed in the device.No hole or damage was identified in the pump; however, following compression, the pump bulb remained deflated with an indentation and slowly refilled, with fluid attempting transfer to the cylinders.The device was removed and replaced with an alternate device during the same procedure.There were no reported patient complications.
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.Deflation issue, inflation issue and mechanical issue are acknowledged within the instructions for use (ifu) and are not related to off-label use or failure to follow instructions.Based on the information available the cause that contributed to the reported event cannot be established; therefore, a conclusion code of cause not established 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: 25437446
• Report Number: 2124215-2026-30571
• Device Sequence Number: 10359094
• Product Code: JCW
• UDI-Device Identifier: 00878953009780
• UDI-Public: (01)00878953009780(17)280308(10)1100919174
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1100919174
• 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: 05/12/2026
• Initial Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 03/09/2026
• 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
• Patient Age: 50 YR
• Patient Sex: Male