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

Model Number	72404434
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced difficulty using the device and was unable to operate the pump.A surgical procedure was performed, during which a possible kink in the tubing was identified, causing the system relief feature to activate.However, the pump functioned normally in the operating room.The ms pump was explanted.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404156.Serial number: n/a.Batch/lot number: 1100700214.Model/catalog description: reservoir 100 ml pc/iz.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced difficulty using the device and was unable to operate the pump.A surgical procedure was performed, during which a possible kink in the tubing was identified, causing the system relief feature to activate.However, the pump functioned normally in the operating room.The ms pump was explanted.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404156.Serial number: n/a.Batch/lot number: 1100700214.Model/catalog description: reservoir 100 ml pc/iz.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.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 event of mechanical malfunction (leaks, incomplete inflation/deflation, kinking) 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 the cause that contributed to the reported event cannot be established.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: 25876872
• Report Number: 2124215-2026-38775
• Device Sequence Number: 20858806
• Product Code: JCW
• UDI-Device Identifier: 00191506021351
• UDI-Public: (01)00191506021351(17)270227(10)1100685602
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 08/27/2026

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: 72404434
• Device Catalogue Number: 72404434
• Device Lot Number: 1100685602
• 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: 06/24/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 02/27/2025
• 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: 74 YR
• Patient Sex: Unknown