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

Model Number	72404252
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was unable to cycle the cylinders and presented for revision surgery.During the procedure, the explanted cylinders were observed to have what appeared to be damage to the silicone layer.A replacement surgery was performed, and new cylinders were implanted.No patient complications were reported, and the patient is expected to fully recover.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ipp underwent a thorough analysis.The cylinders and pump were visually and microscopically inspected, and leak tested; the pump was also functionally tested.Under microscope, it was identified that both cylinders had a detached outer sleeve, broken fabric threads, a hole in the outer tube from kink resistant tubing (krt) wear in the proximal end, one of the cylinders also had its krt worn to the filament, and the filaments were extended.It was also revealed during leakage testing of the cylinders that there were leaks from the krt in the proximal ends.Regarding the pump, no anomalies were found during microscopic examination and leakage testing.However, it did no pass the activation tests when attempted.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications prior to distribution.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 review of the ams 700 hazard analysis was completed and confirmed that the event of mechanical problem was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, the detached outer sleeves identified in the cylinders, as well as the leaks and the pump activation problem could have caused or contributed to the reported clinical observation of cosmetic appearance and mechanical problems.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 (ncep-00181844) 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.

• 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: 50842884
• Report Number: 2124215-2026-50217
• Device Sequence Number: 10039795
• Product Code: JCW
• UDI-Device Identifier: 00878953003603
• UDI-Public: (01)00878953003603(17)250228(10)1100266907
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/21/2026

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: 02/28/2025
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 1100266907
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male