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

Model Number	72401455
Medical Device Problem Codes	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	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, used the first day of the aware month.
Event or Problem Description
It was reported that the patient had an ambicor penile prosthesis implanted that was no longer functioning.A replacement surgery was requested.No patient complications were reported.
Event or Problem Description
It was reported that the patient had this ambicor penile prosthesis replaced as it was no longer functioning.No patient complications were reported.
Additional Manufacturer Narrative
G2: report source and report source (other).
Additional Manufacturer Narrative
G2: report source and report source (other).
Event or Problem Description
It was reported that the patient had an ambicor penile prosthesis implanted that was no longer functioning.A replacement surgery was requested.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this ambicor penile prosthesis (app) at our quality assurance laboratory, the returned components underwent a thorough analysis.The first cylinder had wear at a fold in the middle of the cylinder body; broken fabric threads were present.A hole that led to a leak was found in the middle of the cylinder body due to a sharp instrument consistent with explant.The kink resistant tubing (krt) was worn down to the filament.The second cylinder had wear at a fold in the middle of the cylinder body.The krt was worn down to the filament.No leaks were found.No damage was identified in relation to the pump.Based on the information available and analysis results, the reported clinical event of a mechanical issue was confirmed.
Event or Problem Description
It was reported that the patient had this ambicor penile prosthesis replaced as it was no longer functioning.No patient complications were reported.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16329770
• Report Number: 2124215-2023-05562
• Device Sequence Number: 17840007
• Product Code: FHW
• UDI-Device Identifier: 00878953000992
• UDI-Public: 00878953000992
• 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: 2016
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 05/04/2023

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: 03/18/2020
• Device Model Number: 72401455
• Device Catalogue Number: 72401455
• Device Lot Number: 0927384001
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023; 02/28/2023; 04/12/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 02/08/2023; 03/15/2023; 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2015
• 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