MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS AMBICOR; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72401450
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient felt his ambicor penile prosthesis device was sometimes auto inflating.A revision surgery was performed to replace the device.After explanting the ambicor, the physician found there were no visible malfunctions or issues.A new three-piece penile implant device was implanted.There were no patient complications.
Event or Problem Description
It was reported that the patient felt his ambicor penile prosthesis device was sometimes auto inflating.A revision surgery was performed to replace the device.After explanting the ambicor, the physician found there were no visible malfunctions or issues.A new three piece penile implant device was implanted.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.Microscope inspection revealed both ambicor cylinders had wear at the fold in the proximal end and distal end of the cylinder, not passing the test.However, both cylinders passed the leakage test.Pump passed microscope inspection showing no damage or abnormalities and passed the leak test.Based on the information available and analysis results, the allegation of spontaneous inflation was unable to be confirmed and a clear probable cause for the event cannot be established; therefore, a conclusion code of cause not established was assigned to this investigation.

• Brand Name: AMS AMBICOR
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• 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: 22992590
• Report Number: 2124215-2025-61835
• Device Sequence Number: 13141431
• Product Code: FHW
• UDI-Device Identifier: 00878953000947
• UDI-Public: (01)00878953000947(17)241207(10)1000367576
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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): 10/20/2025

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: 12/07/2024
• Device Model Number: 72401450
• Device Catalogue Number: 72401450
• Device Lot Number: 1000367576
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male