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

Model Number	72401451
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that his ambicor penile prosthesis (app) device stopped working a couple of weeks earlier.The patient reported he had not used the device much over the last 10 years, but he would like to have it replaced.His original doctor, who is now retired, stated the device could not be replaced due to scar tissue.
Additional Manufacturer Narrative
Additional manufacturer narrative: b3 - date of event was not provided, estimated date entered.
Additional Manufacturer Narrative
Additional manufacturer narrative: b3 - date of event was not provided, estimated date entered.
Event or Problem Description
It was reported by the patient that his ambicor penile prosthesis (app) device stopped working a couple of weeks earlier.The patient reported he had not used the device much over the last 10 years, but he would like to have it replaced.His original doctor, who is now retired, stated the device could not be replaced due to scar tissue.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• 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: 20082443
• Report Number: 2124215-2024-53711
• Device Sequence Number: 12684681
• Product Code: FHW
• UDI-Device Identifier: 00878953000954
• UDI-Public: 00878953000954
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: Health Professional
• Device Expiration Date: 07/22/2015
• Device Model Number: 72401451
• Device Catalogue Number: 72401451
• Device Lot Number: 665250004
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/02/2024
• Date Device Manufactured: 08/18/2010
• 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 Age: 67 YR
• Patient Sex: Male