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

Model Number	72404268
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis was removed as it would not inflate due to an unknown fluid leak.A new inflatable penile prosthesis was implanted.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis at our quality assurance laboratory, the returned components underwent a thorough analysis.Were made.The reservoir was visually inspected, and leak tested.The reservoir kink resistant tubing (krt) was worn to the filament.The reservoir passed the leak test.The pump was visually inspected, and leak tested.The pump passed visual inspection and there were no visual damages or abnormalities found.The pump passed the leak and functional tests.Both cylinders were visually inspected, and leak tested.Both cylinders were visually inspected, and leak tested.Both cylinders passed visual inspection and there were no visual damages or abnormalities found.Both cylinders passed the leakage test.Based on the information available and analysis results, the reported inflation issue and fluid loss were unable to be confirmed and the cause was not established.
Event or Problem Description
It was reported that this inflatable penile prosthesis was removed as it would not inflate due to an unknown fluid leak.A new inflatable penile prosthesis was implanted.No patient complications were reported.

• 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: 17908448
• Report Number: 2124215-2023-56102
• Device Sequence Number: 20807637
• Product Code: FHW
• UDI-Device Identifier: 00878953003764
• UDI-Public: 00878953003764
• 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): 12/21/2023

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: 08/26/2023
• Device Model Number: 72404268
• Device Catalogue Number: 72404268
• Device Lot Number: 1100010521
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 72404155 LOT 1100103103
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown