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

Model Number	72401451
Medical Device Problem Codes	Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the cylinders from this ambicor penile prosthesis (app) were not inflating when the patient used the pump.During evaluation, the physician attempted to inflate the device and found it working properly.A surgical procedure was performed in which the original device was explanted and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that the cylinders from this ambicor penile prosthesis (app) were not inflating when the patient used the pump.During evaluation, the physician attempted to inflate the device and found it working properly.Fluid loss was observed in the device, and the pump bulb remained flat.A surgical procedure was performed in which the original device was explanted and replaced.There were no patient complications reported.
Event or Problem Description
It was reported that the cylinders from this ambicor penile prosthesis (app) were not inflating when the patient used the pump.During evaluation, the physician attempted to inflate the device and found it working properly.Fluid loss was observed in the device, and the pump bulb remained flat.A surgical procedure was performed in which the original device was explanted and replaced.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 first cylinder was visually and microscopically inspected and leak tested.A hole was identified in the proximal end of the first cylinder caused by a sharp instrument, and the cylinder did not pass the leakage test.The second cylinder was visually inspected and leak tested.No damage or abnormalities were observed, and the cylinder passed all testing performed.The pump was visually inspected and leak tested.No damage or abnormalities were observed, and the pump passed all testing performed.Based on the available test results and investigation, the reported allegations of cylinder difficult to inflate, fluid leak, and pump collapsed/dimpled/flat could not be confirmed.The reported hole or perforation was confirmed as a secondary failure caused during the explant procedure because it is consistent with 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.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

• 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: 22286935
• Report Number: 2124215-2025-39737
• Device Sequence Number: 15591287
• Product Code: FHW
• UDI-Device Identifier: 00878953000954
• UDI-Public: (01)00878953000954(17)260909(10)1000593257
• 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: 2024
• 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): 11/04/2025

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: 09/09/2026
• Device Model Number: 72401451
• Device Catalogue Number: 72401451
• Device Lot Number: 1000593257
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 10/10/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/18/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown