MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX? TENACIO? Pump; prosthesis, penis, inflatable

Model Number	72404452
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was no longer functioning properly and fluid loss from the system was reported.During surgical exploration, a break was identified in the tubing above the pump, resulting in fluid loss.The pump was replaced with a tenacio pump, the reservoir was replaced and refilled, and the existing cylinders were retained.There were no patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was no longer functioning properly and fluid loss from the system was reported.During surgical exploration, a break was identified in the tubing above the pump, resulting in fluid loss.The pump was replaced with a tenacio pump, the reservoir was replaced and refilled, and the existing cylinders were retained.There were no patient complications reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Correction to field c2/d10: concomitant product/therapy (1).Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100663745.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, the tenacio pump of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The component was microscopically inspected, leak and functionally tested.Microscopic examination revealed that the left pump strain relief was torn at the junction where it connects to the pump.The pump kink resistant tubing (krt) had worn to the filament near the window quick connect.A leak was identified from the torn strain relief.The pump performed as expected during functional testing.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the events of device has a fluid leak and disconnection were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, the reason for the device fluid leak and tube disconnection was most likely determined to be the tear identified at the strain relief and pump block junction; therefore, a conclusion code of quality control deficiency 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: 24022672
• Report Number: 2124215-2026-01584
• Device Sequence Number: 21070910
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72404452
• Device Catalogue Number: 72404452
• Device Lot Number: 1100646906
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/24/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown