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

Model Number	72404238
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1000572622.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).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.Mechanical issue, fluid leak, device operates differently than expected and hole/perforated 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.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced an inability to pump the device.During a revision surgery, the physician identified a sticky pump and a fluid leak in the system, associated with a hole in the reservoir.The pump and reservoir were explanted and replaced, while the cylinders remained implanted and functional.There were no patient complications.

• 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: 25311431
• Report Number: 2124215-2026-28573
• Device Sequence Number: 10541657
• Product Code: JCW
• UDI-Device Identifier: 00878953003511
• UDI-Public: (01)00878953003511(17)230408(10)1000555065
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• 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): 05/27/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/08/2023
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1000555065
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/27/2026
• Date Device Manufactured: 04/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male