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

Model Number	72401454
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with an ambicor penile prosthesis (app) stated that he was unable to deflate the left side of the device.The patient was suggested to contact his urologist for next steps.No additional information was provided.

• 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: 24948320
• Report Number: 2124215-2026-21678
• Device Sequence Number: 18649435
• Product Code: FHW
• UDI-Device Identifier: 00878953000985
• UDI-Public: (01)00878953000985(17)220131(10)161671001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 72401454
• Device Catalogue Number: 72401454
• Device Lot Number: 0161671001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/28/2026
• 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
• Patient Age: 75 YR
• Patient Sex: Male