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

Model Number	72404452
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) pain during device deflation, and while inflated, exhibited a left corporal curvature.It was reported that the patient was oversized during original procedure.The ipp was explanted, a full washout was performed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) pain during device deflation, and while inflated, exhibited a left corporal curvature.It was reported that the patient was oversized during original procedure.The ipp was explanted, a full washout was performed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).Updated evaluation conclusion codes h6.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported clinical observation of the size incorrect for patient are most likely due to a measurement error during the original implantation procedure.The provided event description indicates the device was in good condition when the package of the original device was opened.The evidence from the product record review did not identify a potential product quality issue or new patient harm.Additionally, the patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use (ifu).

• 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: 23211610
• Report Number: 2124215-2025-69379
• Device Sequence Number: 21087408
• Product Code: JCW
• UDI-Device Identifier: 00191506021436
• UDI-Public: (01)00191506021436(17)261022(10)1100616896
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/17/2025

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 Model Number: 72404452
• Device Catalogue Number: 72404452
• Device Lot Number: 1100616896
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 10/22/2024
• 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: UPN 720185-01 / LOT 1100633100.; RESERVOIR: UPN 720185-01 / LOT 1100633100.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male