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

Model Number	72404252
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) would not inflate properly, as the patient experienced issues with the pump not working well.The pump bulb was reported to stay flat.A surgical procedure was performed in which the existing device was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory ams 700 underwent a thorough analysis.The cylinders underwent microscopical inspection and leakage testing.Both cylinders passed the visual inspection, as no damage or abnormalities were identified.Additionally, both components passed the leakage test performed.The pump underwent microscopical examination; leakage and functional testing was also performed.Upon microscopical inspection, no damages or abnormalities were noted.The pump passed the leakage test; however, upon functional testing, the component did not pass the third activation test.The reservoir underwent microscopical inspection and leakage testing.No damage or abnormalities were identified upon microscopical examination; the reservoir also passed the leakage test performed.The device history record (dhr) 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 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 information available and analysis results, a conclusion code of cause traced to component failure was assigned.The clinical observation of inflation difficulty was most likely exhibited by the pump not passing the activation test, as if the pump does not activate correctly, the cylinders would not inflate with fluid when the pump is attempted to be activated.This record was identified during a retrospective review of complaint events; an electronic medical device report (emdr) was not previously submitted per applicable reporting criteria.Boston scientific has opened a nonconforming events and prevention investigation ((b)(4)) to determine the potential cause for why an emdr was not previously submitted to the food and drug administration (fda) in accordance with boston scientific's established medical device reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to take action(s), as necessary.Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100730997.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).

• 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: 50870441
• Report Number: 2124215-2026-50696
• Device Sequence Number: 18447421
• Product Code: JCW
• UDI-Device Identifier: 00878953003603
• UDI-Public: (01)00878953003603(17)260828(10)1100578621
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 08/28/2026
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 1100578621
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 08/28/2024
• 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