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

Model Number	72404231
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) underwent a revision surgery during which the physician confirmed a rupture in the cylinder/pump tubing, and the system was found to be empty.The device was explanted and replaced.There were no reported patient complications.
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.Hole/perforated and fluid leak are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.Additionally, it is concluded that the cause of the allegation cannot be established without product return.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) underwent a revision surgery during which the physician confirmed a rupture in the cylinder/pump tubing, and the system was found to be empty.The device was explanted and replaced.There were no reported patient complications.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The first cylinder exhibited wear at a fold in the proximal end and middle of the cylinder.The first cylinder also exhibited wear on the outer sleeve consistent with rubbing against the second cylinder.The first cylinder passed the leakage test.The second cylinder exhibited wear at a fold in the middle and distal end of the cylinder.The second cylinder also exhibited wear on the outer sleeve consistent with rubbing against the first cylinder.The second cylinder passed the leakage test.Microscopic examination identified contamination consistent with bodily fluid within the ms pump.The ms pump kink resistant tubing (krt) components exhibited wear to the filament.One clear cylinder krt exhibited filament exposure consistent with wear.The ms pump passed the leak test.Functional testing of the ms pump was not performed to avoid damage to the test equipment.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 excess force or friction on silicone leading to stress, strains, holes, or tears, 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 and the analysis results, the allegation of a device fluid leak and tubing hole/perforation is unable to be confirmed.A conclusion code of cause not established 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: 24323234
• Report Number: 2124215-2026-07971
• Device Sequence Number: 18643253
• 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: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 11/07/2018
• Device Model Number: 72404231
• Device Catalogue Number: 72404231
• Device Lot Number: 0154596005
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2016
• 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