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

Model Number	72404250
Medical Device Problem Codes	Degraded (1153); Mechanical Problem (1384)
Health Effect - Clinical Codes	Erosion (1750); Discomfort (2330)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced cylinder erosion, discomfort and the device was not working as expected as the cylinder had an aneurysm.A surgical procedure was performed to remove and replace the ipp.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number 720185-01 serial number n/a batch/lot number 813951018 model/catalog description reservoir flat iz 100 ml unique identifier (udi) # (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The ms pump was visually inspected, leak and functionally tested.The ms pump passed the visual inspection.No damage or abnormalities were found.No leaks were found in the ms pump.The pump passed the functional test.The cylinders were visually inspected and tested for leaks.The first cylinder outer had fatigue from bulged in the proximal end of the cylinder.The first cylinder had bulged when inflated with syringe.The second cylinder passed the visual inspection.No damage or abnormalities were found.No leaks were found in the second cylinder.The reservoir was visually inspected and tested for leaks.The reservoir passed visual inspection.No damage or abnormalities were found.No leaks were found in the reservoir.Based on the information available and the analysis results, the most likely reason for the bulge and the mechanical issue was that the first cylinder had bulged at the proximal end.The dhr review 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 discomfort, erosion, bulge, and mechanical issue were 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, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced cylinder erosion, discomfort and the device was not working as expected as the cylinder had an aneurysm.A surgical procedure was performed to remove and replace the ipp.No additional 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: 24201525
• Report Number: 2124215-2026-05027
• Device Sequence Number: 9855408
• Product Code: JCW
• UDI-Device Identifier: 00878953003580
• UDI-Public: (01)00878953003580(17)130728(10)724357005
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 07/28/2013
• Device Model Number: 72404250
• Device Catalogue Number: 72404250
• Device Lot Number: 724357005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2011
• 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: 813951018.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male