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

Model Number	72404253
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for reservoir is (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.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the cylinders of this inflatable penile prosthesis (ipp) did not inflate.The pump did not work properly, a lack of any liquide move to cylinders were noticed.As a result, the device was explanted and replaced.No patient complications reported.
Event or Problem Description
It was reported that the cylinders of this inflatable penile prosthesis (ipp) did not inflate.The pump did not work properly, a lack of any liquide move to cylinders were noticed.As a result, the device was explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally tested, and leak tested.Microscopic examination revealed that the poppet rod was misaligned within the ms pump.As a result, the functional test was not performed.Due to the misaligned poppet rod, the ms pump did not pump water correctly, and water flowed in and out of the reservoir kink resistant tubing (krt).The cylinders were microscopically inspected and leak tested; both cylinders exhibited wear at a fold in the proximal and middle portions of the cylinder, and no leaks were identified.The reservoir was also microscopically inspected and leak tested, and wear was observed at a fold in the reservoir shell, with no leaks identified.Risk review: a risk review was completed using d055985 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.The device history record (dhr): the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Labeling review: 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.Based on the available information and analysis results, the pump poppet rod misalignment, supports the reported clinical observations of cylinder inflation issue and pump mechanical issue.

• Brand Name: AMS 700 LGX 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: 23927685
• Report Number: 2124215-2025-93671
• Device Sequence Number: 18395442
• Product Code: JCW
• UDI-Device Identifier: 00878953003610
• UDI-Public: (01)00878953003610(17)240725(10)1100162492
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 07/25/2024
• Device Model Number: 72404253
• Device Catalogue Number: 72404253
• Device Lot Number: 1100162492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN 720185-01/ LOT 1100188767; RESERVOIR: UPN 720185-01/ LOT 1100188767
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown