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

Model Number	72404014
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device that would not inflate.A revision surgery was performed, during which the physician suspected a fluid leak within the system.The device was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100880320.Model/catalog description: reservoir flat iz 100 ml.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.Inflation issue, mechanical issue and fluid leak are acknowledged within the instructions for use (ifu) and are not related to off-label use or failure to follow instructions.

• Brand Name: AMS 700 CXR
• 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: 50857421
• Report Number: 2124215-2026-50472
• Device Sequence Number: 9936178
• Product Code: JCW
• UDI-Device Identifier: 00878953002712
• UDI-Public: (01)00878953002712(17)260429(10)1000561760
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/29/2026
• Device Model Number: 72404014
• Device Catalogue Number: 72404014
• Device Lot Number: 1000561760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 04/30/2021
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 165 LB