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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
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 surgical procedure was performed, during which a hole in the right cylinder was noted.Both cylinders and pump were removed and replaced, while the existing reservoir was kept in the patient and a new one was added to the system.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 surgical procedure was performed, during which a hole in the right cylinder was noted.Both cylinders and pump were removed and replaced, while the existing reservoir was kept in the patient and a new one was added to the system.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.Fluid loss due to a hole located in the corner of a fold in the middle of each cylinder was identified.In addition, both cylinders exhibited wear at the fold in their middle and proximal ends.The pump was microscopically inspected, leak and functionally tested.The component passed both leakage and functional tests.During microscopic evaluation, it was noted that its kink resistant tubing (krt) was worn down to the filament.Based on the information available and analysis results, the hole and the fluid loss identified in each cylinder could have caused or contributed to the reported clinical observations.

• 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: 20833119
• Report Number: 2124215-2024-75513
• Device Sequence Number: 17151929
• Product Code: JCW
• UDI-Device Identifier: 00878953003948
• UDI-Public: 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: 2014
• Device Explanted Year: 2024
• 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): 12/30/2024

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: 10/16/2019
• Device Model Number: 72404292
• Device Catalogue Number: 72404292
• Device Lot Number: 904364004
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2014
• 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: 904356005; PUMP: UPN: 72404310 / LOT: 904356005; RESERVOIR: UPN: 72404161 / LOT: 899125010; RESERVOIR: UPN: 72404161 / LOT: 899125010
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male