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

Model Number	72404173
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was experiencing a mechanical issue.During the procedure, fluid loss was identified in the right cylinder.Both the outer silicone wall and the inner dacron layer were found to be ruptured.The cylinder was difficult to remove as tissue had become incorporated between the layers, which caused additional damage during removal.All components were replaced, and the device was disposed.There were no further patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) was experiencing a mechanical issue.During the procedure, fluid loss was identified in the right cylinder.Both the outer silicone wall and the inner dacron layer were found to be ruptured.The cylinder was difficult to remove as tissue had become incorporated between the layers, which caused additional damage during removal.All components were replaced, and the device was disposed.There were no further patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404209 , batch/lot number: 0178406005, model/catalog description: pump ms iz, unique identifier (udi) #:(b)(4), model number/catalog number: 72404155, batch/lot number: 0160042016, model/catalog description: reservoir flat iz 100 ml, unique identifier (udi) #: (b)(4).Correction to field b1: adverse event/product problem.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom is a known risk associated with this device type and indicated as such in the instructions for use.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: AMS 700 CX
• 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: 23294381
• Report Number: 2124215-2025-72426
• Device Sequence Number: 20055996
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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 Expiration Date: 04/19/2018
• Device Model Number: 72404173
• Device Catalogue Number: 72404173
• Device Lot Number: 0130017004
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 07/29/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PUMP: UPN: 72404209 / LOT: 0178406005.; RESERVOIR: UPN: 72404155 / LOT: 0160042016.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male