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); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) exhibited fluid loss.A surgical procedure was performed to remove and replace the ipp.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number 720185-01.Serial number n/a.Batch/lot number 1100633903.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.Fluid leak is acknowledged within the dfu and is 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.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) exhibited fluid loss.A surgical procedure was performed to remove and replace the ipp.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number 720185-01, batch/lot number 1100633903, model/catalog description reservoir flat iz 100 ml, unique identifier (udi) # (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and tested for leaks.Microscope examination revealed that the first cylinder had a hole at corner of a fold in the middle of the cylinder.The first cylinder had wear at fold in the proximal end and middle of the cylinder.The first cylinder had a leak at corner of a fold in the middle of the cylinder.The second cylinder had a hole at corner of a fold in the proximal end of the cylinder.The second cylinder had a hole in the middle of the cylinder from sharp instrument.The second cylinder had wear at fold in the proximal end and middle of the cylinder.The second cylinder had a leak at corner of a fold in the proximal end of the cylinder and had a leak from sharp instrument damage.The ms pump was microscopically inspected, leak and functionally tested.The ms pump passed the visual inspection.No damage or abnormalities were found.No leaks were found in the pump.The ms pump passed the functional test.The rear tip extenders (rtes) were visually inspected.Both rtes had wear from rubbing against each other.The reservoir was visually inspected and tested for leaks.The reservoir passed the visual inspection.No damage or abnormalities were found.No leaks were found in the reservoir.Based on the information available and analysis results, the reason for the device fluid leak was most likely determined to be the leaks at the corners of folds from both cylinders.The sharp instrument damage on the second cylinder probably occurred during the explant surgery and will be considered a secondary failure.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the events of device has a fluid leak and mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of cause traced to component failure 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: 24575235
• Report Number: 2124215-2026-13531
• Device Sequence Number: 10391900
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 07/19/2026
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1100552653
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown