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

Model Number	72404155
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) pump was not cycling due a fluid loss from the reservoir.A surgical procedure was performed to replace the system.There were no patient complications.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) pump was not cycling due a fluid loss from the reservoir.A surgical procedure was performed to replace the system.There were no patient complications.

• Brand Name: AMS 700 SPHERICAL RESERVOIR
• 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: 21708348
• Report Number: 2124215-2025-18766
• Device Sequence Number: 4515110
• Product Code: JCW
• UDI-Device Identifier: 00878953003207
• UDI-Public: (01)00878953003207(17)180518(10)135566016
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 05/18/2018
• Device Model Number: 72404155
• Device Catalogue Number: 72404155
• Device Lot Number: 0135566016
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/03/2025
• Date Device Manufactured: 05/18/2016
• 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: LOT: 0141327001, UPN: 72404257; PUMP: LOT: 0141327001, UPN: 72404257
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown