MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700? CX TENACIO? PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404432
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01, serial number: n/a, batch/lot number: 1100735211, model/catalog description: reservoir, flat, iz, 100 ml, unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Difficult to inflate is acknowledged within the dfu and is not related to off-label use or failure to follow instructions.Based on the information available the cause that contributed to the reported event cannot be established; therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with difficulty using the tenacio pump and reported that the implant was not rigid enough.A revision surgery was performed, during which the physician confirmed that the pump cycled well in the operating room prior to incision.The physician explanted and replaced the cylinders and the tenacio pump with same size cylinders and an ms pump.There were no patient complications.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with difficulty using the tenacio pump and reported that the implant was not rigid enough.A revision surgery was performed, during which the physician confirmed that the pump cycled well in the operating room prior to incision.The physician explanted and replaced the cylinders and the tenacio pump with same size cylinders and an ms pump.There were no patient complications.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Upon receipt of additional information and further review by the manufacturer, report 2124215-2026-16381 was identified as a duplicate of report 2124215-2026-15284.This duplicate record does not represent a new or separate reportable event.Based on the information reviewed, all new and relevant information will be submitted and maintained under report 2124215-2026-15284.

• 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: 24690041
• Report Number: 2124215-2026-16381
• Device Sequence Number: 15884590
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 05/28/2026

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: 1100733227
• Was Device Available for Evaluation?: No
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 05/21/2025
• 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: 66 YR
• Patient Sex: Male