MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CX MS Pump; prosthesis, penis, inflatable

Model Number	72404239
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was not working properly.The patient was unable to achieve maximum rigidity, as the valve would release prematurely, resulting in deflation of the implant.As a result, the pump was explanted and replaced.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.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: 72404156 serial number: n/a batch/lot number: 1100743459 model/catalog description: reservoir 100 ml pc/iz unique identifier (udi) # (b)(4).
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was not working properly.The patient was unable to achieve maximum rigidity, as the valve would release prematurely, resulting in deflation of the implant.As a result, the pump was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, had a leakage test and a functional teste were no damage or abnormalities were found.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 mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) and spontaneous deflation were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.The reported clinical observation of mechanical issue or deflation could not be confirmed; based on the information available and analysis results a conclusion code of no problem detected was assigned to this investigation.Model number/catalog number: 72404156.Serial number: n/a.Batch/lot number: 1100743459.Model/catalog description: reservoir 100 ml pc/iz.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: 25661241
• Report Number: 2124215-2026-34618
• Device Sequence Number: 10447496
• Product Code: JCW
• UDI-Device Identifier: 00878953003528
• UDI-Public: (01)00878953003528(17)270826(10)1100785056
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 08/26/2026
• Device Model Number: 72404239
• Device Catalogue Number: 72404239
• Device Lot Number: 1100785056
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2026
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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 Age: 67 YR
• Patient Sex: Male