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

Model Number	72404292
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	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an implantation surgery, during the test of the inflatable penile prosthesis (ipp), it did not work properly.As a result of the inspection, it was confirmed that the cylinder had a hole.Due to this, a surgical procedure was performed to replace both cylinders and a pump.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis at our quality assurance laboratory, this device was thoroughly analyzed.Microscopic analysis identified both cylinders had wear at fold in the proximal end and distal end of the cylinder.The device was tested too.Both cylinders successfully passed leakage and test.The pump was also tested, concluding that the pump did not present any damage or abnormality and it passed leakage and functional tests.The allegation of a hole/perforation was unable to be confirmed.Based on the information provided, cause not established was selected as the most probable cause for the complaint.
Event or Problem Description
It was reported that after an implantation surgery, during the test of the inflatable penile prosthesis (ipp), it did not work properly.As a result of the inspection, it was confirmed that the cylinder had a hole.Due to this, a surgical procedure was performed to replace both cylinders and a pump.There were no patient complications.

• Brand Name: AMS 700 LGX
• 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: 21531969
• Report Number: 2124215-2025-13748
• Device Sequence Number: 7735768
• Product Code: JCW
• UDI-Device Identifier: 00878953003948
• UDI-Public: (01)00878953003948(17)290314(10)1100470455
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/26/2025

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 Model Number: 72404292
• Device Catalogue Number: 72404292
• Device Lot Number: 1100470455
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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:4161, LOT:1100470297.; RESERVOIR: UPN:4161, LOT:1100470297.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male