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	03/28/2025
Type of Reportable Event	Serious Injury
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 crack in the right cylinder connecting tube was noted.Both cylinders and pump were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.The first cylinder presented wear at fold in its proximal and distal ends, along with a hole and a leak in its kink resistant tubing (krt) from fatigue.The second cylinder exhibited wear at fold in its proximal and distal ends, but no leaks were identified.The pump was microscopically inspected, leak and functionally tested.Pump tubing was not returned for analysis as it was cut down to the pump block.No leaks were identified in the component; however, the pump did not pass activation testing during functional examination.Based on the information available and analysis results, the leak identified in the first cylinder krt could have caused or contributed to the reported clinical observation of device not working properly and a crack in the cylinder connecting tube.Additionally, the pump not passing functional evaluation could affect product performance.
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 crack in the right cylinder connecting tube was noted.Both cylinders and pump were removed and replaced.No patient complications were reported.

• 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: 21950767
• Report Number: 2124215-2025-28117
• Device Sequence Number: 8691768
• Product Code: JCW
• UDI-Device Identifier: 00878953003948
• UDI-Public: (01)00878953003948
• 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: 2023
• 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): 06/30/2025

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
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 1000280272.; PUMP: UPN: 72404310 / LOT: 1000280272.; RESERVOIR: UPN: 72404161 / LOT: 1100304594.; RESERVOIR: UPN: 72404161 / LOT: 1100304594.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male