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

Model Number	72404251
Medical Device Problem Codes	Nonstandard Device (1420); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number 72404156.Serial number n/a.Batch/lot number 591203006.Model/catalog description reservoir 100 ml pc/iz.Unique identifier (udi) # (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and tested for leaks.The first cylinder had tool marks and a hole in the proximal end at the kink resistant tubing (krt) junction from sharp instrument.The first cylinder had wear at fold in the proximal end and distal end of the cylinder.The first cylinder had a leak from sharp instrument damage in the proximal end of the cylinder at the krt junction.The second cylinder had wear at fold in the proximal end and middle of the cylinder.No leaks were found in the second cylinder.The ms pump was microscopically inspected, leak and functionally tested.The pump kink resistant tubing (krt) were worn to the filament and had scaling.No leaks were found in the pump.The pump did not pass the inflation test 1.The reservoir was microscopically inspected, ante tested for leaks.The reservoir had a hole on the reservoir adapter strain relief from sharp instrument damage.No leaks were found in the reservoir.Based on the information available and analysis results, no allegation was reported against the returned device; however, the ms pump not passing the inflation test 1 could affect the product performance.The sharp instrument damage to the first cylinder most likely occurred during the explant surgery and is considered a secondary failure.The device history record (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 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, 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) surgery due to unspecified reasons; however, upon analysis of the returned components, multiple device issues were identified.No additional information was 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: 24618804
• Report Number: 2124215-2026-14647
• Device Sequence Number: 21242641
• Product Code: JCW
• UDI-Device Identifier: 00878953003597
• UDI-Public: (01)00878953003597(17)110429(10)594543001
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: 04/29/2011
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Device Lot Number: 594543001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2009
• 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: 84 YR
• Patient Sex: Male