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

Model Number	72404258
Medical Device Problem Codes	Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (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 this inflatable penile prosthesis (ipp) presented the cylinders ruptured.The ipp was removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).Updated evaluation conclusion codes h6.Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Both cylinders were microscopically inspected and leak testing.It was found that the first cylinder had a hole in the outer tube and broken fabric threads from kink resistant tubing (krt) wear at the proximal end.The outer sleeve was detached, and wear was observed at folds in the proximal, middle, and distal ends of the cylinder.Additionally, the cylinder did not pass the leakage testing due to a leak from krt wear in the proximal end.The second cylinder had wear at folds in the proximal, middle, and distal ends of the cylinder.However, the cylinder passed the leakage testing.Momentary squeeze (ms) pump kink resistant tubing (krt) was microscopically inspected and leak testing.It was observed that the ms pump krt were worn to the filament.Ms pump passed the leakage test, however, did not pass the functional tests.Finally, the flat reservoir was microscopically inspected and leak testing, it was observed to had wear at a fold in reservoir shell.Flat reservoir passed leakage test.Based on the information available and analysis results, the hole and leak identified in one of the cylinders could have caused or contributed to the reported clinical observation of mechanical problem.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented the cylinders ruptured.The ipp was removed and replaced.There were no patient complications reported.

• 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: 23521878
• Report Number: 2124215-2025-80984
• Device Sequence Number: 18630733
• Product Code: JCW
• UDI-Device Identifier: 00878953003665
• UDI-Public: (01)00878953003665(17)180402(10)127712005
• 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 Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 04/02/2018
• Device Model Number: 72404258
• Device Catalogue Number: 72404258
• Device Lot Number: 0127712005
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: UPN 720185-01 / LOT 0144628009.; RESERVOIR: UPN 720185-01 / LOT 0144628009.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown