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

Model Number	72404232
Medical Device Problem Codes	Nonstandard Device (1420); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404156 serial number: n/a batch/lot number: 901976004 model/catalog description: reservoir 100 ml pc/iz unique identifier (udi) #: (b)(4).B3: date is unknown, so estimated date was entered.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The microscopic visual inspection of the cylinder revealed that the first cylinder had wear at fold in the proximal end and distal end of the cylinder, and had a hole in the distal end of the cylinder from sharp instrument which is standard for the explant process.The second cylinder had wear at a fold in the proximal end and distal end of the cylinder.It also had a hole in the proximal end of the cylinder from sharp instrument, and had a hole in the distal end of the cylinder from sharp instrument which is standard for the explant process.The microscopic visual inspection of the pump revealed that the pump kink resistant tubing (krt) was worn to the filament, and the black krt had a hole from sharp instrument damage which is standard for the explant process.The leakage test of the cylinder revealed that the first cylinder had a leak from sharp instrument in the distal of the cylinder.The second cylinder had a leak from sharp instrument in the proximal end of the cylinder, and had a leak from sharp instrument in the distal of the cylinder.The functional test of the pump revealed that the pump failed activation test 2 and 3.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) is defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Mechanical issue 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 pump not passing the functional test could have caused or contributed to the device being removed.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was explanted and returned without initial reporter and any performance allegation information.However, upon analysis of the returned components, the pump did not pass functional test.No additional information was provided.

• 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 ; 5086521217
• MDR Report Key: 25325883
• Report Number: 2124215-2026-28811
• Device Sequence Number: 9881034
• Product Code: JCW
• UDI-Device Identifier: 00878953003450
• UDI-Public: (01)00878953003450(17)161120(10)908681005
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 11/20/2016
• Device Model Number: 72404232
• Device Catalogue Number: 72404232
• Device Lot Number: 908681005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2014
• 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 Sex: Unknown