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

Model Number	72404236
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was empty.The ipp was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The first cylinder was microscopically inspected and leak testing.It was found a hole at corner of a fold and buckling folds in the proximal end of the cylinder.The cylinder did not pass the leakage testing due to the leak found at corner of a fold in the middle.The second cylinder was microscopically inspected and leak testing.It was found buckling folds in the proximal end and middle of the cylinder.The second cylinder had a hole in the outer tube from wear in the proximal end of the cylinder.The second cylinder passed the leakage test.Momentary squeeze (ms) pump was microscopically inspected, and contamination (bodily fluid) was found within the ms pump.Ms pump kink resistant tubing (krt) were worn to the filament.Ms pump passed the leakage test.Flat reservoir passed visual inspection and leakage test.Based on the information available and analysis results, the hole and leak identified in one of the cylinders could have caused or contributed to the reported clinical observation of mechanical problem.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was empty.The ipp was explanted and replaced.There were no patient complications reported.

• Brand Name: AMS 700 CX 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: 21810633
• Report Number: 2124215-2025-22319
• Device Sequence Number: 7568463
• Product Code: JCW
• UDI-Device Identifier: 00878953003498
• UDI-Public: (01)00878953003498(17)250511(10)1100298596
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 05/29/2025

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: 05/11/2025
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 1100298596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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: RESERVOIR: LOT 1100419569 UPN 720185-01.; RESERVOIR: LOT 1100419569 UPN 720185-01.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown