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

Model Number	72404292
Medical Device Problem Codes	Mechanical Problem (1384); 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	04/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis was not working properly.Two weeks later, a revision surgery was performed, during which a tear in the right cylinder was noted.Cylinder and pump were removed and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis was not working properly.Two weeks later, a revision surgery was performed, during which a tear in the right cylinder was noted.Cylinder and pump were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The cylinder was microscopically inspected and tested for leaks.A hole and broken fabric threads were noted in the proximal end of the component, along with wear at fold in the proximal, middle and distal portions of the cylinder.In addition, a leak from wear in its proximal end was identified.The pump was microscopically inspected, leak and functionally tested.Upon microscopic evaluation, no damage or abnormalities were noted.Additionally, no leaks were identified in the component.However, the pump did not pass activation test during functional examination.Based on the information available and analysis results, the leak identified in the cylinder could have caused or contributed to the reported clinical observations.In addition, the pump not passing functional testing could affect product performance.Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (b)(4).

• 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: 22052080
• Report Number: 2124215-2025-32231
• Device Sequence Number: 8908302
• Product Code: JCW
• UDI-Device Identifier: 00878953003948
• UDI-Public: (01)00878953003948(17)200406(10)930647003
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 04/06/2020
• Device Model Number: 72404292
• Device Catalogue Number: 72404292
• Device Lot Number: 930647003
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2015
• 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: PUMP: UPN: 72404310 / LOT: 927028004.; PUMP: UPN: 72404310 / LOT: 927028004.; RESERVOIR: UPN: 72404161 / LOT: 926505011.; RESERVOIR: UPN: 72404161 / LOT: 926505011.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male