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); Material Puncture/Hole (1504); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced dissatisfaction with device pump.Upon inspection, a minimal fluid in the reservoir was noticed.The physician suspected a hole in the reservoir or cylinders, possibly due to suture placement or unrelated surgical procedure.As a result, the cylinders and pump were explanted and replaced.The reservoir was drained, retained in patient and a new one was placed.No patient complications were reported.
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.(insert dhr statement, refer to verbiage database & ifu labeling section relevant to as reported).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 model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100036694 model/catalog description: reservoir flat iz 100 ml unique identifier (udi) #: (b)(4).

• 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: 25673512
• Report Number: 2124215-2026-34939
• Device Sequence Number: 10452905
• Product Code: JCW
• UDI-Device Identifier: 00878953003511
• UDI-Public: (01)00878953003511(17)230820(10)1100008098
• 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: 2020
• 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): 06/30/2026

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: 08/20/2023
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1100008098
• 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: 06/02/2026
• Initial Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 08/20/2021
• 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: 83 YR
• Patient Sex: Male