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

Model Number	72404011
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) repair surgery.The existing ipp was removed with no patient complications.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) repair surgery.Additionally, the patient experienced suppuration and fungal infection in the scrotum.The physician suspects the device did not cause or contribute to the infection.However, the ipp was removed with no additional patient complications.
Event or Problem Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) repair surgery.Additionally, the patient experienced suppuration and a fungal infection in the scrotum.However, the physician believes that the infection is unrelated to the device.The ipp was removed without any additional complications for the patient.
Additional Manufacturer Narrative
Correction made to b2 outcomes attributed to adv event, b5 describe event or problem, h6 patient codes, and h6 evaluation conclusion code.

• Brand Name: AMS 700 CXR
• 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: 21124076
• Report Number: 2124215-2024-83518
• Device Sequence Number: 15623793
• Product Code: JCW
• UDI-Device Identifier: 00878953002682
• UDI-Public: 00878953002682
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 03/11/2025

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: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1100188578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/12/2025; 02/21/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/10/2025; 03/11/2025
• Date Device Manufactured: 09/14/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 75 KG