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

Model Number	72404264
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed and a non-conformance was identified.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01, serial number: n/a, batch/lot number: 1100741332, model/catalog description: reservoir flat iz 100 ml, unique identifier (udi) #: (b)(4).Upon receipt at our post market quality assurance laboratory, this inflatable penile prosthesis (ipp) was thoroughly inspected and analyzed.Microscopic analysis of the cylinders noted wear in a fold at the proximal end of both cylinders; the pump kink resistant tubing (krt) exhibited wear from rubbing against itself.The pump passed leakage testing but did not pass functional activation testing.A risk review was completed using the ams700 hazard analysis and confirmed that the event of mechanical malfunction (leaks, incomplete inflation/deflation, kinking) was 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 available information and analysis findings, a most probable conclusion of cause traced to component failure was assigned to this event.

• Brand Name: AMS 700 CXR 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: 25820434
• Report Number: 2124215-2026-37843
• Device Sequence Number: 10362186
• Product Code: JCW
• UDI-Device Identifier: 00878953003726
• UDI-Public: (01)00878953003726(17)251008(10)1100373225
• 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): 07/14/2026

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: 10/08/2025
• Device Model Number: 72404264
• Device Catalogue Number: 72404264
• Device Lot Number: 1100373225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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 Sex: Unknown