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

Model Number	72404452
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis ipp presented with a device that auto deflates.A surgery was performed, during which the physician explanted the device.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).Upon receipt at the quality assurance laboratory, the returned device underwent a comprehensive evaluation.During microscope inspection, it was revealed that the first cylinder had a hole in the outer tube due to sharp instrument damage at the proximal end, resulting in it not passing the test, although it did pass the leakage test.The second cylinder and reservoir both passed microscope inspection, with no damage or abnormalities found, and passed the leakage test for both components.The pump passed visual inspection and the leakage test; however, functional testing did not pass, not passing inflation test 1 and 2.Based on the information available and analysis results, the reported allegation of spontaneous deflation was confirmed and most likely determined to be the pump failure of inflation tests 1 and 2 from the functional test, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a device that auto deflates.A surgery was performed, during which the physician explanted the device.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).Upon receipt at the quality assurance laboratory, the returned device underwent a comprehensive evaluation.During microscope inspection, it was revealed that the first cylinder had a hole in the outer tube due to sharp instrument damage at the proximal end, resulting in it not passing the test, although it did pass the leakage test.The second cylinder and reservoir both passed microscope inspection, with no damage or abnormalities found, and passed the leakage test for both components.The pump passed visual inspection and the leakage test; however, functional testing did not pass, not passing inflation test 1 and 2.Based on the information available and analysis results, the reported allegation of spontaneous deflation was confirmed and most likely determined to be the pump failure of inflation tests 1 and 2 from the functional test, a conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS 700 LGX? TENACIO? 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: 22514163
• Report Number: 2124215-2025-46675
• Device Sequence Number: 21148454
• Product Code: JCW
• UDI-Device Identifier: 00191506021436
• UDI-Public: (01)00191506021436(17)261015(10)1100612051
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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 Model Number: 72404452
• Device Catalogue Number: 72404452
• Device Lot Number: 1100612051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• 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 1100565024, UPN 72018501; RESERVOIR LOT 1100565024, UPN 72018501
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male