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

Model Number	72404258
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented fluid loss.The ipp was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).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 a hole in the proximal end of the cylinders from sharp instrument.Both cylinders had wear at fold in the proximal end and middle of the cylinder.Both cylinders did not pass the leakage testing.Flat reservoir passed visual inspection and leakage test.The sharp instrument damage found on the device is considered a secondary failure, so the allegation of a fluid leak is unable to be confirmed.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented to a fluid loss.The ipp was explanted 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: 21910654
• Report Number: 2124215-2025-22870
• Device Sequence Number: 9081291
• Product Code: JCW
• UDI-Device Identifier: 00878953003665
• UDI-Public: (01)00878953003665(17)220213(10)1000396460
• 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: 2020
• 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): 05/27/2025

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: 02/13/2022
• Device Model Number: 72404258
• Device Catalogue Number: 72404258
• Device Lot Number: 1000396460
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2020
• 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: LOT 1000412012 UPN 720185-01; RESERVOIR: LOT 1000412012 UPN 720185-01
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown