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

Model Number	72401455
Medical Device Problem Codes	Degraded (1153); Inflation Problem (1310); Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an ambicor penile prosthesis (app) experienced pain in the region of the prosthesis.A cystoscopy was performed, revealing that the device was not properly deployed, was not functioning correctly, and showed dilation at the base of the penis.The device remains implanted, and a revision surgery is planned.No further patient complications have been reported.
Additional Manufacturer Narrative
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 dhr, the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The patient symptom is a known risk associated with this device type/procedure, and it is noted as such as in the instructions for use.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the patient with an ambicor penile prosthesis (app) experienced pain in the region of the prosthesis.A cystoscopy was performed, revealing that the device was not properly deployed, was not functioning correctly, and showed dilation at the base of the penis.The device remains implanted, and a revision surgery is planned.No further patient complications have been reported.

• 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: 23598483
• Report Number: 2124215-2025-82415
• Device Sequence Number: 18464165
• Product Code: FHW
• UDI-Device Identifier: 00878953000992
• UDI-Public: (01)00878953000992(17)210308(10)124891004
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 12/30/2025

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: 03/08/2021
• Device Model Number: 72401455
• Device Catalogue Number: 72401455
• Device Lot Number: 0124891004
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 03/08/2016
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Male