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

Model Number	72401454
Medical Device Problem Codes	Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed as it would not deflate.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 cylinders and pump were visually inspected, and leak tested.The kink resistant tubing (krt) was cut off from the pump.There were no visual damages or abnormalities noted in the pump.No leaks were found.The first cylinder had wear and a leak at a fold in the proximal end.Broken fabric threads were found in the distal end of the cylinder body with a bulge present when it was inflated with a syringe.The second cylinder had wear at a fold in the proximal end.No leaks were found.Based on the information available and analysis results, the device deflation issue was most likely attributed to the cylinder bulging and fluid leak that was identified in the analysis.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis removed as it would not deflate.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: 16812390
• Report Number: 2124215-2023-19919
• Device Sequence Number: 5733316
• Product Code: FHW
• UDI-Device Identifier: 00878953000985
• UDI-Public: 00878953000985
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: 01/26/2016
• Device Model Number: 72401454
• Device Catalogue Number: 72401454
• Device Lot Number: 693577003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2011
• 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: Male