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

Model Number	72401453
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an ambicor penile prosthesis app presented with fluid loss in the system.A revision surgery was performed, during which the physician confirmed fluid loss in the distal right cylinder.The device was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that a patient with an ambicor penile prosthesis app presented with fluid loss in the system.A revision surgery was performed, during which the physician confirmed fluid loss in the distal right cylinder.The device was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that a patient with an ambicor penile prosthesis (app) presented with fluid loss in the system.A revision surgery was performed, during which the physician confirmed fluid loss in the distal right cylinder.The device was explanted and replaced.No patient complications were 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.Fluid leak is acknowledged within the dfu and is not related to off-label use or failure to follow instructions.Based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.Additionally, it is concluded that the cause of the allegation cannot be established without product return.Based on the information available the cause that contributed to the reported event cannot be established.

• 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: 22366485
• Report Number: 2124215-2025-43177
• Device Sequence Number: 13120670
• Product Code: FHW
• UDI-Device Identifier: 00878953000978
• UDI-Public: (01)00878953000978(17)231106(10)1000187763
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 02/10/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/06/2023
• Device Model Number: 72401453
• Device Catalogue Number: 72401453
• Device Lot Number: 1000187763
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 01/15/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/18/2025; 02/10/2026
• Date Device Manufactured: 11/07/2018
• 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 Age: 68 YR
• Patient Sex: Male