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

Model Number	72404262
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) valve collapsed, it was not working, and the right cylinder is apparently broken.The reservoir is empty.Due to this, a surgical procedure was scheduled.The patient outcome is unknown.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, no visual or functional testing was able to be completed.With all the available information, boston scientific concludes that the reported complaint was not confirmed.Based on the information available, a conclusion code cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) valve collapsed, it was not working, and the right cylinder is apparently broken.The reservoir is empty.Due to this, a surgical procedure was scheduled.The patient outcome is unknown.

• Brand Name: AMS 700 CXR MS PUMP
• 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: 21449725
• Report Number: 2124215-2025-10449
• Device Sequence Number: 7723944
• Product Code: JCW
• UDI-Device Identifier: 00878953003702
• UDI-Public: (01)00878953003702(17)230628(10)1000587818
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/02/2025

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: 06/28/2023
• Device Model Number: 72404262
• Device Catalogue Number: 72404262
• Device Lot Number: 1000587818
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male