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

Model Number	72404432
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Unintended Deflation (4061)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp), experienced difficulty operating the device.The patient reported that the deflation button would stick and would not release when pressed.The patient also reported episodes of auto inflation during sleep and stated that the device auto deflated during attempted use.Additionally, the patient indicated that repeated pumping did not appear to fully inflate the cylinders.Upon inspection, reservoir appeared to be scarred in vivo.As a result, the device was explanted and replaced.No further patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally tested, and leak tested.Microscope inspection revealed that the pump kink resistant tubing (krt) were worn to the filament.The pump did not meet activation test requirements; however, no leaks were identified.The cylinder was microscopically inspected and leak tested.No anomalies were found with the cylinders.The reservoir was microscopically inspected, and leak tested.The microscope test identified that the reservoir krt had wear at the end where it connects to the pump.No leaks were identified.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 mechanical malfunction (leaks, incomplete inflation/ deflation, kinking).Spontaneous deflation, spontaneous inflation, and adhesions 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 available information and analysis results, the pump not passing the activation test supports the reported clinical observations of deflation issue, pump inflation issue, and device inflation issue.Therefore, a conclusion code of cause traced to component failure.Was assigned to this investigation.This record was identified during a retrospective review of complaint events; an electronic medical device report (emdr) was not previously submitted per applicable reporting criteria.Boston scientific has opened a nonconforming events and prevention investigation (b)(4) to determine the potential cause for why an emdr was not previously submitted to the food and drug administration (fda) in accordance with boston scientific's established medical device reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to take action(s), as necessary.Model number/catalog number: 720185-01, serial number: n/a, batch/lot number: 1100584061, model/catalog description: reservoir flat iz 100 ml, unique identifier (udi)#: (b)(4).

• Brand Name: AMS 700? CX 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: 50900285
• Report Number: 2124215-2026-51255
• Device Sequence Number: 17642701
• Product Code: JCW
• UDI-Device Identifier: 00191506021337
• UDI-Public: (01)00191506021337(17)270103(10)1100650421
• Combination Product (Y/N): Y
• Initial Reporter State: WY
• 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
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 72404432
• Device Catalogue Number: 72404432
• Device Lot Number: 1100650421
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male