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

Model Number	72401450
Medical Device Problem Codes	Inflation Problem (1310); Nonstandard Device (1420); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this ambicor penile prosthesis (app) experienced inflation issues.During removal, visible damage was observed in the left cylinder of the device.A surgical procedure was performed in which the existing device was explanted and replaced with an ams 700.There were no patient complications reported.
Event or Problem Description
It was reported that the patient with this ambicor penile prosthesis (app) experienced inflation issues.During removal, visible damage was observed in the left cylinder of the device.A surgical procedure was performed in which the existing device was explanted and replaced with an inflatable penile prosthesis (ipp).There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ambicor penile prosthesis (app) underwent a thorough analysis.The cylinders were visually and microscopically examined, and leak tested.The first cylinder passed the leakage test, and no visual damages or abnormalities were found.The inner tube of the second cylinder exhibited a hole from fatigue, along with broken fabric threads at the proximal end.In addition, the second cylinder did not pass the leakage test as a bulge was observed at the proximal end when inflated using a syringe.The pump was visually examined, and no anomalies were identified.Based on analysis results, the presence of a hole due to material fatigue in the inner tube of the second cylinder, along with the resulting bulge at its proximal end, may have caused or contributed to the reported clinical observations.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ambicor penile prosthesis (app) underwent a thorough analysis.The cylinders were visually and microscopically examined, and leak tested.The first cylinder passed the leakage test, and no visual damages or abnormalities were found.The inner tube of the second cylinder exhibited a hole from fatigue, along with broken fabric threads at the proximal end.In addition, the second cylinder did not pass the leakage test as a bulge was observed at the proximal end when inflated using a syringe.The pump was visually examined, and no anomalies were identified.Based on analysis results, the presence of a hole due to material fatigue in the inner tube of the second cylinder, along with the resulting bulge at its proximal end, may have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that the patient with this ambicor penile prosthesis (app) experienced inflation issues.During removal, visible damage was observed in the left cylinder of the device.A surgical procedure was performed in which the existing device was explanted and replaced with an inflatable penile prosthesis (ipp).There were no patient complications 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: 22377553
• Report Number: 2124215-2025-43495
• Device Sequence Number: 4463319
• Product Code: FHW
• UDI-Device Identifier: 00878953000947
• UDI-Public: (01)00878953000947(17)231112(10)1000191583
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/13/2026

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: 11/12/2023
• Device Model Number: 72401450
• Device Catalogue Number: 72401450
• Device Lot Number: 1000191583
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 03/19/2026
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/14/2025; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown