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

Model Number	72404438
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404156 serial number: n/a batch/lot number: 1100743450 model/catalog description: reservoir 100 ml pc/iz unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced difficulty inflating the device and stated that excessive and forceful pumping was required, which was challenging due to his hydrocele.The device never really inflated properly.Troubleshooting was performed, including several appointments and training sessions; however, it was unsuccessful in resolving the issue.As a result, the pump was explanted and replaced.No further patient complications were reported.

• 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: 25698421
• Report Number: 2124215-2026-35479
• Device Sequence Number: 15875185
• Product Code: JCW
• UDI-Device Identifier: 00191506021399
• UDI-Public: (01)00191506021399(17)270317(10)1100694800
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 07/27/2026

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: 72404438
• Device Catalogue Number: 72404438
• Device Lot Number: 1100694800
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2026
• 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: 06/04/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 03/17/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male