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	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the right cylinder connecting tube was identified.The cause of the crack in the connecting tube was not detailed by the hospital.The cylinder and pump were removed and replaced with no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The explanted cylinder was returned and microscopically inspected, and leak tested.Microscope examination revealed that the cylinder kink resistant tubing (krt) had a hole from wear and had wear at fold in the proximal end, middle, and distal end of the cylinder body.The leakage test revealed that the cylinder krt leaked due to fatigue.The pump was microscopically inspected, leak, and functionally tested.Microscope examination revealed that contamination (bodily fluid) was found within the pump.The pump tubing was cut down to the pump block; the tubing was not returned for analysis.The pump passed the leakage test.To avoid damaging the test equipment, the pump was not functionally tested.Based on the information available and analysis results, the reason for the mechanical issue and the hole/perforation was most likely determined to be the cylinder krt leak from the functional test performed; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a crack in the right cylinder connecting tube was identified.The cause of the crack in the connecting tube was not detailed by the hospital.The cylinder and pump were removed and replaced with 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: 21761833
• Report Number: 2124215-2025-19823
• Device Sequence Number: 8582637
• Product Code: JCW
• UDI-Device Identifier: 00878953003948
• UDI-Public: (01)00878953003948(17)210201(10)120120001
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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 Expiration Date: 02/01/2021
• Device Model Number: 72404292
• Device Catalogue Number: 72404292
• Device Lot Number: 120120001
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2016
• 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: 1100215496.; PUMP: UPN: 72404310 / LOT: 1100215496.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male