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

Model Number	72404463
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted with an inflatable penile prosthesis (ipp) experienced scrotal pain.A surgical procedure was performed during which the physician identified purulent material (pus) within the scrotum, confirming the presence of an infection at the implant site.The affected area was thoroughly cleaned and the ipp was subsequently explanted and replaced with a tactra device.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100823328.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that a patient implanted with an inflatable penile prosthesis (ipp) experienced scrotal pain.A surgical procedure was performed during which the physician identified purulent material (pus) within the scrotum, confirming the presence of an infection at the implant site.The affected area was thoroughly cleaned and the ipp was subsequently explanted and replaced with a tactra device.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100823328 model/catalog description: reservoir flat iz 100 ml unique identifier (udi) #:(b)(4) the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.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 events of infection, pain and purulent discharge were 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, a conclusion code of adverse event related to procedure was assigned to this investigation, since there are procedural related factors that may have contributed to the observed issue.

• Brand Name: AMS 700¿ CXR 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: 25856053
• Report Number: 2124215-2026-38448
• Device Sequence Number: 5204183
• Product Code: JCW
• UDI-Device Identifier: 00191506021528
• UDI-Public: (01)00191506021528(17)260712(10)1100546874
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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 Expiration Date: 07/12/2026
• Device Model Number: 72404463
• Device Catalogue Number: 72404463
• Device Lot Number: 1100546874
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 07/12/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male