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

Model Number	72401454
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right cylinder of this ambicor penile prosthesis inflated.The device was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this ambicor penile prosthesis was removed as the patient was unable to use the device as the right cylinder could not be inflated.A new ambicor penile prosthesis was implanted.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The cylinders 1 and 2 were microscopically examined had wear at a fold in the middle of the cylinders.Cylinder 1 had a hole with a leak and broken fabric threads in the proximal end of the cylinder from a sharp instrument.Cylinder 2 had wear at a fold in the middle of the cylinder and a bulge when inflated with a syringe.Cylinders 1 and 2 did not pass the leakage testing performed.The pump passed visual inspection and leakage testing.

• 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: 19009211
• Report Number: 2124215-2024-19234
• Device Sequence Number: 20943706
• Product Code: FHW
• UDI-Device Identifier: 00878953000985
• UDI-Public: 00878953000985
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 06/21/2024

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: 09/13/2017
• Device Model Number: 72401454
• Device Catalogue Number: 72401454
• Device Lot Number: 790096005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 03/30/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2012
• 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