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

Model Number	72401452
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cylinders of the ambicor penile prosthesis did not inflate.The patient underwent surgery to replace the device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ambicor penile prosthesis underwent a thorough analysis.The cylinders were visually and microscopically examined, and leak tested.The first cylinder had two holes in the proximal end and middle of the cylinder, consistent with sharp instrument damage, leak was present.The second cylinder had a hole in the proximal end from sharp instrument damage, a leak was present.The pump was visually and microscopically examined, and leak tested.No anomalies were found with the pump.The reported inflation issue was not confirmed, the sharp instrument damage on both cylinders most likely occurred during the explant surgery.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the cylinders of the ambicor penile prosthesis did not inflate.The patient underwent surgery to replace the device.There were no patient complications.

• 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: 20010693
• Report Number: 2124215-2024-51799
• Device Sequence Number: 7230773
• Product Code: FHW
• UDI-Device Identifier: 00878953000961
• UDI-Public: 00878953000961
• 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: 2021
• 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): 10/24/2024

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: 06/12/2023
• Device Model Number: 72401452
• Device Catalogue Number: 72401452
• Device Lot Number: 1000120084
• 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: 10/07/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2018
• 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