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

Model Number	72404238
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100486591 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.Fluid leakage is acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.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.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) had fluid loss.A surgical procedure was performed during which the device was explanted and replaced.No additional information was provided.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) had fluid loss.A surgical procedure was performed during which the device was explanted and replaced.No additional information was provided.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100486591.Model/catalog description: reservoir flat iz 100 ml.Unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The microscopic visual inspection of both cylinder revealed that the first cylinder had wear at a fold in the middle of the cylinder, and a hole in the kink resistant tubing (krt) and the proximal end of the cylinder from sharp instrument which is standard for the explant process.The second cylinder had wear at a fold in the middle of the cylinder, and had a hole at corner of a fold in the proximal end of the cylinder.The leakage test of both cylinder revealed that the first cylinder had a leak from sharp instrument damage which is standard for the explant process at the krt and at the proximal end of the cylinder.The second cylinder had a leak at a corner of a fold in the proximal end of the cylinder.The pump passed leakage testing, functional testing, and visual inspection with no damage or abnormalities found.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event of device has a fluid leak was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Fluid leakage is acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation as the device fluid leak was most likely determined to be the second cylinder leak at the corner of a fold from the functional test performed and the analysis of the available information.The sharp instrument damage on cylinder 1 most likely occurred during the explant surgery and will be considered a secondary failure.

• Brand Name: AMS 700 CX MS 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 ; +1(508)652-1217
• MDR Report Key: 25448738
• Report Number: 2124215-2026-30789
• Device Sequence Number: 9557065
• Product Code: JCW
• UDI-Device Identifier: 00878953003511
• UDI-Public: (01)00878953003511(17)251113(10)1100395065
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/02/2026

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: 11/13/2025
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1100395065
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• 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: 05/27/2026
• Supplement Date Received by Manufacturer: 07/01/2026; 08/31/2026; 09/30/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/07/2026; 09/21/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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 Sex: Unknown