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

Model Number	72404233-12
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical implantation procedure for an inflatable penile prosthesis (ipp), during test inflation, the surgeon was unable to deflate the device without continuously pressing the release button.Standard troubleshooting was performed, and although the device could eventually be deflated, the surgeon elected not to use the implant.A new device was used to complete the procedure.No patient complications were reported.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: 25834079
• Report Number: 2124215-2026-38161
• Device Sequence Number: 13130845
• Product Code: JCW
• UDI-Device Identifier: 00878953009797
• UDI-Public: (01)00878953009797(17)280411(10)1100951873
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2026

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: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1100951873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/15/2026
• Date Device Manufactured: 04/12/2026
• 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 Sex: Unknown