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

Model Number	72404155
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for preconnect is (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly with issues noted in the pump mechanism.During the surgical procedure, it was also discovered that the reservoir had migrated from its intended position.The physician suspected that the tubing was kinked, as the device functioned appropriately once tension was applied to the tubing.This confirmed that the pump itself was operating correctly.Despite this, the physician elected to replace the tenacio pump with an ms pump and also replaced the reservoir.No patient complications were reported.

• 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: 24258056
• Report Number: 2124215-2026-06336
• Device Sequence Number: 13139960
• Product Code: JCW
• UDI-Device Identifier: 00878953003207
• UDI-Public: (01)00878953003207(17)261106(10)1100625299
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 72404155
• Device Catalogue Number: 72404155
• Device Lot Number: 1100625299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 11/06/2024
• 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: PRECONNECT: UPN: 72404452 / LOT: 1100569546
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male