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

Model Number	72404452
Medical Device Problem Codes	Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) was unable to inflate the device.The pump remained compressed and flat due to fluid loss caused by a break in the pump connecting tubing.A surgical procedure was performed, during which the ipp was removed and replaced with a tactra malleable device at the patient's request due to manual dexterity issues.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: (b)(4) serial number: n/a batch/lot number: (b)(4) model/catalog description: (b)(4) unique identifier (udi) #: (b)(6).

• 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: 50070023
• Report Number: 2124215-2026-40580
• Device Sequence Number: 16015206
• Product Code: JCW
• UDI-Device Identifier: 00191506021436
• UDI-Public: (01)00191506021436(17)270228(10)1100686858
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: 1100686858
• 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: 07/03/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 02/28/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male