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

Model Number	72401455
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with his ambicor penile prosthesis (app) device not inflating.Pelvic and penis magnetic resonance imaging (mri) was performed which confirmed there was a mechanical issue with the pump.The physician suspected the device not functioning was due to fluid loss from the device.The app was explanted, and a new inflatable penile prosthesis (ipp) device was implanted.There were no patient complications.
Additional Manufacturer Narrative
The exact event date was not available, therefore 07/01/2025 was used as an estimate, based on the reported onset occurring within the last three months.Correction to field a2: date of birth and age at time of event.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, it cannot be confirmed what the cause of the fluid leak, inflation issue, and mechanical issue was.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.Based on the information available the cause that contributed to the reported event cannot be established; therefore, the conclusion code of cause not established was selected for this investigation.
Additional Manufacturer Narrative
The exact event date was not available, therefore 07/01/2025 was used as an estimate, based on the reported onset occurring within the last three months.
Event or Problem Description
It was reported that the patient presented with his ambicor penile prosthesis (app) device not inflating.Pelvic and penis magnetic resonance imaging (mri) was performed which confirmed there was a mechanical issue with the pump.The physician suspected the device not functioning was due to fluid loss from the device.The app was explanted, and a new inflatable penile prosthesis (ipp) device was implanted.There were no patient complications.
Additional Manufacturer Narrative
The exact event date was not available, therefore 07/01/2025 was used as an estimate, based on the reported onset occurring within the last three months.Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.The ambicor pump passed visual inspection.No visual damage or abnormalities were identified.The first cylinder exhibited wear at a fold in the proximal end of the cylinder, with a hole identified at the corner of the fold.The first cylinder also exhibited wear at a fold in the distal end of the cylinder.A leak was identified at the corner of a fold in the proximal end of the first cylinder.The second cylinder exhibited two holes in the proximal end of the cylinder consistent with sharp instrument damage.The second cylinder also exhibited wear at folds in both the proximal and distal ends of the cylinder.Two leaks were identified in the proximal end of the second cylinder corresponding to the areas of sharp instrument damage.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the allegations of mechanical issue, inflation issue, fluid leak were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available and the analysis results, the allegation of device fluid leak and device inflation issue was most likely attributed to the hole/leak identified at the corner of a fold in the first cylinder.Additionally, a pump mechanical issue could not be confirmed, as the pump passed visual inspection and could not be functionally tested.The sharp instrument damage observed on the second cylinder most likely occurred during the explant surgery and was considered a secondary failure.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient presented with his ambicor penile prosthesis (app) device not inflating.Pelvic and penis magnetic resonance imaging (mri) was performed which confirmed there was a mechanical issue with the pump.The physician suspected the device not functioning was due to fluid loss from the device.The app was explanted, and a new inflatable penile prosthesis (ipp) device was implanted.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: 23463996
• Report Number: 2124215-2025-76672
• Device Sequence Number: 10431609
• Product Code: FHW
• UDI-Device Identifier: 00878953000992
• UDI-Public: (01)00878953000992(17)200505(10)933060003
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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: 05/05/2020
• Device Model Number: 72401455
• Device Catalogue Number: 72401455
• Device Lot Number: 933060003
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 02/13/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/11/2025; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2015
• 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: 72 YR
• Patient Sex: Male