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

Model Number	72404439
Medical Device Problem Codes	Inflation Problem (1310); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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 the patient with an inflatable penile prosthesis (ipp) was unable to fully inflate the cylinders with the tenacio pump.A surgical procedure was performed to remove the tenacio pump and replace with a ms pump.The original cylinders and reservoir remained implanted.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting #.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) was unable to fully inflate the cylinders with the tenacio pump.A surgical procedure was performed to remove the tenacio pump and replace with a ms pump.The original cylinders and reservoir remained implanted.No patient complications were reported.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) was unable to fully inflate the cylinders with the tenacio pump.A surgical procedure was performed to remove the tenacio pump and replace with a ms pump.The original cylinders and reservoir remained implanted.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field c2/d10: concomitant product/therapy.Model number/catalog number: 720185-01, batch/lot number: 1100587201, 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 tenacio pump was microscopically inspected, leak and functionally tested.The component passed the visual inspection and leakage test.The component did not pass the deflation test.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications prior to distribution.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) and difficult to inflate 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 reported allegation of pump inflation was unable to be confirmed; therefore, a conclusion code of cause not established was assigned to this investigation.However, the pump not passing the deflation test could affect the product performance.

• 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: 23286033
• Report Number: 2124215-2025-71496
• Device Sequence Number: 17532580
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2026

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 Expiration Date: 08/26/2026
• Device Model Number: 72404439
• Device Catalogue Number: 72404439
• Device Lot Number: 1100576057
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2025
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 08/25/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/16/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0142-2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male