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

Model Number	72404281
Medical Device Problem Codes	Inflation Problem (1310); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) implant device presented to their implanting physician as they were unable to inflate their ipp device.The patient reported that initially the pump felt very hard.The physician performed a physical examination and was unable to inflate the ipp device when pressing the pump.Ultrasound studies were performed and confirmed that the reservoir was intact and contained fluid inside.The physician believed that the most likely/suspected cause was the pump component.A surgical procedure was performed during which the entire device was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Model number/catalog number: 720182-01.Serial number: n/a.Batch/lot number: unknown.Model/catalog description: reservoir, flat, 100 ml.Unique identifier (udi) #: unknown.At this time, the investigation is in progress.Once the investigation is completed the final report will be submitted.

• 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: 25815532
• Report Number: 2124215-2026-37721
• Device Sequence Number: 18816173
• Product Code: JCW
• UDI-Device Identifier: 00878953003849
• UDI-Public: (01)00878953003849(17)250318(10)1000412811
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

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: 03/18/2025
• Device Model Number: 72404281
• Device Catalogue Number: 72404281
• Device Lot Number: 1000412811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2020
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 81 KG