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

Model Number	72404161
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for lgx 15: (b)(4).D4 unique identifier (udi) for pump: (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 hole in reservoir was found.The ipp was removed and replaced, the existing reservoir was kept in the patient.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for lgx 15: (b)(4).D4 unique identifier (udi) for pump: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The momentary squeeze (ms) pump was microscopically inspected and leak testing.It was found that ms pump tubing was cut down to the pump block.Ms pump passed leak test.Additionally, ms pump did not pass activation tests.One cylinder was microscopically inspected and passed visual inspection and leakage test.Finally, the remaining cylinder was microscopically inspected and had a hole in the outer tube from window quick connector (wqc) and kink resistant tubing (krt) wear in the proximal end of the cylinder.The cylinder did not pass the leakage test.Based on the information available and analysis results; the hole and leak identified in one of the cylinders and the ms pump that did not pass activation tests 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 not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in reservoir was found.The ipp was removed and replaced, the existing reservoir was kept in the patient.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: 22294390
• Report Number: 2124215-2025-40035
• Device Sequence Number: 20900693
• Product Code: JCW
• UDI-Device Identifier: 00878953003238
• UDI-Public: (01)00878953003238(17)210502(10)133250016
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/06/2025

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: 05/02/2021
• Device Model Number: 72404161
• Device Catalogue Number: 72404161
• Device Lot Number: 0133250016
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: LGX 15: UPN 72404292 / LOT 0143195001.; LGX 15: UPN 72404292 / LOT 0143195001.; PUMP: UPN 72404310 / LOT 1100295032.; PUMP: UPN 72404310 / LOT 1100295032.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male