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

Model Number	72404432
Medical Device Problem Codes	Inflation Problem (1310); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experience difficulty inflating to full pressure.In the operating room, the device cycled appropriately; however, the patient was dissatisfied with it.As a result, the tenacio pump and cylinders were explanted and replaced with an ms pump and cylinders.No additional information was provided.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem and b2: date of event.Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: n/a.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).Detailed product information for the reservoir was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experience difficulty inflating to full pressure.In the operating room, the device cycled appropriately; however, the patient was dissatisfied with it.As a result, the tenacio pump and cylinders were explanted and replaced with an ms pump and cylinders.No additional information was provided.
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
Model number/catalog number: 720185-01, model/catalog description: reservoir flat iz 100 ml, unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, the cylinders and pump of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and tested for leaks.Both cylinders had a hole in the proximal end of the cylinder from sharp instrument.Both cylinders had wear at fold in the proximal end of the cylinder.Both cylinders had a leak from sharp instrument in the proximal end of the cylinder.The pump was microscopically inspected, leak and functionally tested.The pump kink resistant tubing (krt) had wear.No leaks were found in the pump; and the pump worked as expected during the functional 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 event of difficult to inflate was 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 device difficult to inflate was unable to be confirmed, as the pump passed the functional test.The sharp instrument damage found in both cylinders are considered a secondary failure.Therefore, a conclusion code of cause not established was assigned to this investigation.

• 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: 24641775
• Report Number: 2124215-2026-15284
• Device Sequence Number: 9906295
• Product Code: JCW
• UDI-Device Identifier: 00191506021337
• UDI-Public: (01)00191506021337(17)270521(10)1100733227
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• 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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72404432
• Device Catalogue Number: 72404432
• Device Lot Number: 1100733227
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2026
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 09/02/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/26/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Weight: 237 LB