MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS Ambicor; device impotence mechanical/hydraulic

Model Number	72401453
Medical Device Problem Codes	Inflation Problem (1310); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's ambicor penile prosthesis (app) was not functioning properly, the device exhibited inflation issues and spontaneous deflation.A surgical procedure was performed during which the app was removed and replaced with an inflatable penile prosthesis (ipp).There were no patient complications.

• 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: 25673575
• Report Number: 2124215-2026-34995
• Device Sequence Number: 18755195
• Product Code: FHW
• UDI-Device Identifier: 00878953000978
• UDI-Public: (01)00878953000978(17)260907(10)1000593228
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 09/07/2026
• Device Model Number: 72401453
• Device Catalogue Number: 72401453
• Device Lot Number: 1000593228
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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 Sex: Unknown