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

Model Number	72404267
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the inflatable penile prosthesis (ipp)due to the implant not inflating properly.The physician believed that there was material damage and identified a fluid leak from the device.There were no patient complications reported.
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the inflatable penile prosthesis (ipp)due to the implant not inflating properly.The physician believed that there was material damage and identified a fluid leak from the device.There were no patient complications reported.
Additional Manufacturer Narrative
Upon previous receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned device underwent a thorough analysis.Visual examination of the pump, reservoir, and cylinders did not find any abnormalities.The pump, reservoir, and cylinders passed the leak testing performed.The pump did not pass the functional testing performed related to the deflation test.Based on the information available and analysis results, the clinical observations of inflation issue and mechanical issue were confirmed; however, the reported fluid leak was unable to be confirmed.Due to the confirmed inflation issue, a conclusion of cause traced to component failure was chosen.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• 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: 17827258
• Report Number: 2124215-2023-52849
• Device Sequence Number: 17673370
• Product Code: FHW
• UDI-Device Identifier: 00878953003757
• UDI-Public: 00878953003757
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 12/18/2023

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 Model Number: 72404267
• Device Catalogue Number: 72404267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 12/18/2023
• 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