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

Model Number	72404262
Medical Device Problem Codes	Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3.Date of event: actual event date was unknown; therefore, first day of bsc aware month was selected.
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was sucking flat and had fluid loss.Air was noticed on the pump.The ipp was explanted and replaced.No patient complications reported.

• 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: 21608214
• Report Number: 2124215-2025-15522
• Device Sequence Number: 21198981
• Product Code: JCW
• UDI-Device Identifier: 00878953003702
• UDI-Public: 00878953003702
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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: 10/10/2016
• Device Model Number: 72404262
• Device Catalogue Number: 72404262
• Device Lot Number: 0902737003
• 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: 02/20/2025
• Initial Report FDA Received Date: 03/14/2025
• Date Device Manufactured: 10/10/2014
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male