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

Model Number	72404233-12
Medical Device Problem Codes	Migration (4003); Unintended Deflation (4061)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1000218295.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.Spontaneous deflation, migration, tissue damage and disfigurement are acknowledged within the instructions for use (ifu) and are not related to off-label use or failure to follow instructions.The reported patient symptoms of tissue damage and disfigurement are known risks associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a device that would not maintain rigidity sufficient for penetration, with the patient reporting that the device deflated after 5 to 10 minutes of intercourse.The patient subsequently reported leftward curvature.A revision surgery was performed, during which the physician confirmed cylinder crossover and noted that both cylinders were located in the distal right corporal body.The device was explanted and replaced.There were no further patient complications.

• 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: 25882167
• Report Number: 2124215-2026-38921
• Device Sequence Number: 15454126
• Product Code: JCW
• UDI-Device Identifier: 00878953009797
• UDI-Public: (01)00878953009797(17)210121(10)1000218380
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 07/20/2026

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: 01/21/2021
• Device Model Number: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1000218380
• 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: 06/23/2026
• Initial Report FDA Received Date: 07/20/2026
• Date Device Manufactured: 01/22/2019
• 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: 78 YR
• Patient Sex: Male