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

Model Number	72401451
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an ambicor penile prosthesis (app) device had a cylinder that did not inflate.The app was removed, and an ams 700 inflatable penile prosthesis was implanted.There were no patient complications.
Event or Problem Description
It was reported that the patient with an ambicor penile prosthesis (app) device had a cylinder that did not inflate.The app was removed, and an ams 700 inflatable penile prosthesis was implanted.There were no patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the patient with an ambicor penile prosthesis (app) device had a cylinder that did not inflate.The app was removed, and an ams 700 inflatable penile prosthesis was implanted.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned device underwent a thorough analysis.The cylinders were visually and microscopically inspected.Cylinder one had a leak from wear in the proximal end of the cylinder.Cylinder one had a bulge when inflated with a syringe.Cylinder two passed leakage testing.The pump was visually and microscopically inspected.The pump passed the leakage testing.Analysis confirmed the reported clinical observations.

• 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: 19975656
• Report Number: 2124215-2024-49898
• Device Sequence Number: 8432706
• Product Code: FHW
• UDI-Device Identifier: 00878953000954
• UDI-Public: 00878953000954
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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: 09/13/2021
• Device Model Number: 72401451
• Device Catalogue Number: 72401451
• Device Lot Number: 0149962001
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 10/01/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/04/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown