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

Model Number	72401455
Medical Device Problem Codes	Inflation Problem (1310); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient enrolled in the it matters study with this ambicor penile prosthesis (app) implanted.Approximately six months later, the device exhibited inflation issues; therefore, a medical appointment for device evaluation was scheduled.No further information was reported.
Event or Problem Description
It was reported that the patient with this ambicor penile prosthesis (app) stated he heard a sound when attempting to inflate the device, which then stopped inflating; therefore, a replacement surgery was scheduled.No further information was provided.
Additional Manufacturer Narrative
Device codes detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional 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.
Additional Manufacturer Narrative
Additional information updated: b5: describe event/problem h6: impact codes.Upon receipt of additional information and further review by the manufacturer, it was determined that this event no longer meets the reporting criteria for the device in question, as there was no patient adverse event or device malfunction that required medical or surgical intervention to prevent patient harm.Additionally, there is no information to reasonably suggest that the reported malfunction, or their recurrence, could cause or contribute to death, serious injury, or serious deterioration in the health of a patient, user, or other person.
Event or Problem Description
It was reported that the patient with this ambicor penile prosthesis (app) stated he heard a popping sound when attempting to inflate the device, after which it no longer inflated; however, upon office evaluation, the device was found to be well seated and functional.Additionally, the patient stated he had no issues with the app aside from that single instance.No patient complications were 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: 21112362
• Report Number: 2124215-2024-83298
• Device Sequence Number: 18313378
• Product Code: FHW
• UDI-Device Identifier: 00878953000992
• UDI-Public: (01)00878953000992
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72401455
• Device Catalogue Number: 72401455
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 03/18/2025; 05/20/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 04/04/2025; 05/30/2025
• 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
• Patient Sex: Male