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

Model Number	72404432
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced device auto-inflation and difficulty inflating the device since the initial implant procedure.The auto-inflation was reportedly observed during office evaluations, and the pump was described as feeling gummy during use.A revision procedure was performed during which the tenacio pump was explanted and replaced with an ms pump.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 1100598244.Model/catalog description: reservoir 65 ml pc/iz.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: 50867420
• Report Number: 2124215-2026-50621
• Device Sequence Number: 18810023
• Product Code: JCW
• UDI-Device Identifier: 00191506021337
• UDI-Public: (01)00191506021337(17)261031(10)1100622710
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 72404432
• Device Catalogue Number: 72404432
• Device Lot Number: 1100622710
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 10/31/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Unknown