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

Model Number	72404234-14
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented dissatisfaction stated they were unable to use device.Computed tomography scan showed potential air in the device.Upon removal, a small leak was located in the tubing near the pump.The cylinders were also folded over themselves in the corpora.The ipp was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100425100.Model/catalog description: reservoir flat iz 100 ml.D4 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.Based on the information available the cause that contributed to the reported event cannot be established.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.\ serial number: n/a.\ batch/lot number: 1100425100.\ model/catalog description: reservoir flat iz 100 ml.\ d4 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 device performance allegation cannot be confirmed.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 tissue damage (improper tubing length or placement), patient dissatisfaction (with length, ability to use and nonspecific reasons), therapeutic response altered, device malposition, mechanical malfunction and device have a fluid leak and 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 cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented dissatisfaction stated they were unable to use device.Computed tomography scan showed potential air in the device.Upon removal, a small leak was located in the tubing near the pump.The cylinders were also folded over themselves in the corpora.The ipp was explanted and replaced.There were no patient complications reported.

• 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
• MDR Report Key: 25082299
• Report Number: 2124215-2026-24193
• Device Sequence Number: 10537128
• Product Code: JCW
• UDI-Device Identifier: 00878953009803
• UDI-Public: (01)00878953009803(17)251214(10)1100414239
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 12/14/2025
• Device Model Number: 72404234-14
• Device Catalogue Number: 72404234-14
• Device Lot Number: 1100414239
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 12/15/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male