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

Model Number	72401451
Medical Device Problem Codes	Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Pain (1994); Chills (2191); Hematuria (2558)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with an infected ambicor penile prosthesis (app), testicular pain, and left suprapubic pain.The patient was unable to provide a detailed history and reported falling into a chair and landing on his scrotum.He also reported that in (b)(6) 2024, he had a severe motor vehicle collision, resulting in a traumatic brain injury, broken ribs, a broken back, a broken neck, and a medically induced coma with catheter placement.The patient has not used his app for a while because he has difficulty deflating the pump.The patient also reported fevers, chills, and intermittent hematuria twice a week.A surgical procedure was performed to remove the infected app, during which a significant purulence was noted upon entering the scrotum.An urethroplasty was performed to repair the urethra.Two weeks of antibiotics and foley catheters were required.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient presented with an infected ambicor penile prosthesis (app), testicular pain, and left suprapubic pain.The patient was unable to provide a detailed history and reported falling into a chair and landing on his scrotum.He also reported that in (b)(6) 2024, he had a severe motor vehicle collision, resulting in a traumatic brain injury, broken ribs, a broken back, a broken neck, and a medically induced coma with catheter placement.The patient has not used his app for a while because he has difficulty deflating the pump.The patient also reported fevers, chills, and intermittent hematuria twice a week.A surgical procedure was performed to remove the infected app, during which a significant purulence was noted upon entering the scrotum.An urethroplasty was performed to repair the urethra.Two weeks of antibiotics and foley catheters were required.No additional patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ambicor penile prosthesis (app) underwent a thorough analysis.The cylinders were microscopically inspected.Microscope examination revealed that the first cylinder had a hole in the proximal end of the cylinder from sharp instrument.The first cylinder had wear at fold in the proximal end and distal end of the cylinder.The second cylinder had wear at fold in the proximal end and distal end of the cylinder.The pump was microscopically inspected.Microscope examination revealed that the pump kink resistant tubing (krt) had wear.Based on the information available and analysis results, a conclusion code of known inherent risk of device was assigned to this investigation, as the allegations relate to chills, fever, hematuria, infection, pain, purulent discharge which are addressed in our labeling and risk documentation.

• 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: 21477899
• Report Number: 2124215-2025-12035
• Device Sequence Number: 3491993
• Product Code: FHW
• UDI-Device Identifier: 00878953000954
• UDI-Public: 00878953000954
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 05/18/2022
• Device Model Number: 72401451
• Device Catalogue Number: 72401451
• Device Lot Number: 0174059005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2017
• 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 Age: 71 YR
• Patient Sex: Male