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

Model Number	72404258
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for cxr 16 cm: (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a crack in the right cylinder connecting tube was found.The pump and right cylinder were explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a crack in the right cylinder connecting tube was found.The pump and right cylinder were explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for cxr 16cm: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.One cylinder was microscopically inspected and leak testing and passed both tests.The remaining cylinder was microscopically inspected, it was cut down to the adaptor junction, and it was observed to had buckling folds in the proximal end of the cylinder.The cylinder passed the leakage test.Momentary squeeze (ms) pump was microscopically inspected; the tubing was cut down to the pump block and contamination (bodily fluid) was found within the ms pump.Ms pump passed the leakage test.Based on this investigation a clear probable cause for the event cannot be established.

• Brand Name: AMS 700 LGX 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: 22543472
• Report Number: 2124215-2025-47418
• Device Sequence Number: 15258401
• Product Code: JCW
• UDI-Device Identifier: 00878953003665
• UDI-Public: (01)00878953003665(17)230302(10)1000537471
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/18/2025

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: 03/02/2023
• Device Model Number: 72404258
• Device Catalogue Number: 72404258
• Device Lot Number: 1000537471
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CXR 16CM: UPN (B)(4) / LOT 1000372068.; CXR 16CM: UPN (B)(4) / LOT 1000372068.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male