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

Model Number	72404232
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Nonstandard Device (1420)
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
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented a mechanical problem due to a fluid loss.The ipp was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 1000069912.Model/catalog description: reservoir.Unique identifier (udi): (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) stated he heard a popping sound and that the device was not functioning properly.Upon inspection, fluid loss was identified.As a result, the device was explanted and replaced, and the reservoir was implanted in a different location on the left side.No patient complications were 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: 24872680
• Report Number: 2124215-2026-20031
• Device Sequence Number: 18663098
• Product Code: JCW
• UDI-Device Identifier: 00878953003450
• UDI-Public: (01)00878953003450(17)200318(10)1000074215
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 07/15/2026

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: 03/18/2020
• Device Model Number: 72404232
• Device Catalogue Number: 72404232
• Device Lot Number: 1000074215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/22/2026; 06/18/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/13/2026; 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2018
• 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 Age: 61 YR
• Patient Sex: Male