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

Model Number	72404256
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery due to rupture in one cylinder.The ipp was removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were microscopically inspected, and leak tested.The first cylinder had a hole in the outer tube and broken fabric threads from kink resistant tubing (krt) wear in the proximal end of the cylinder.The outer sleeve was separated starting at the proximal end of the cylinder.The first cylinder had a bulge in the proximal end of the cylinder.The second cylinder had a hole at corner of a fold and broken fabric threads in the middle of the cylinder.The outer sleeve was torn at the middle of the cylinder.The second cylinder presented leak at the corner of a fold in the middle of the cylinder.The pump was microscopically inspected, leak and functionally tested.Microscope examination revealed that the pump krt were worn to the filament, but no leaks were identified.The pump passed the functional test.The reservoir was microscopically inspected, and leak tested.Wear at a fold in reservoir shell was noted, but no leaks were identified.Based on the information available and analysis results, the leak at the corner of a fold found in the second cylinder could have caused or contributed to the reported clinical observation of hole/perforated.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) replacement surgery due to rupture in one cylinder.The ipp was removed and replaced.No patient complications were 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: 22088379
• Report Number: 2124215-2025-34032
• Device Sequence Number: 20800121
• Product Code: JCW
• UDI-Device Identifier: 00878953003641
• UDI-Public: (01)00878953003641(17)160722(10)891128004
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 07/22/2016
• Device Model Number: 72404256
• Device Catalogue Number: 72404256
• Device Lot Number: 891128004
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2014
• 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: 921413002; RESERVOIR: UPN: 720185-01 / LOT: 921413002
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown